Reported trial results for Gastro-oesophageal Reflux Disease
Every Gastro-oesophageal Reflux Disease trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.
43 trials have reported results.
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
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NCT03820947 · results posted 4 September 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT03820947) looked at a device called the VenaSeal™ System, which uses a type of medical glue to close off problem veins in the legs. It was compared against two other approaches: endothermal ablation (ETA, which uses heat to close veins) and surgical stripping (a procedure to physically remove the vein). The trial ran across three groups: 136 people received VenaSeal™ and 139 received ETA in one comparison; 53 received VenaSeal™ and 53 received surgical stripping in another; and a separate group of 125 people with venous leg ulcers received VenaSeal™ on its own. Not everyone completed the trial — completion numbers ranged from 87 to 115 across the randomised groups, and 87 out of 125 completed in the leg ulcer group. The reported data shows two main things were measured for the randomised comparisons at 30 days: patient satisfaction scores and how much of the target vein was successfully treated during the procedure. Satisfaction was captured using two questionnaires scored from 0 to 36 (higher meaning greater satisfaction). For the VenaSeal™ versus ETA comparison, the reported peri-procedural satisfaction scores were 30.8 (VenaSeal™) and 29.6 (ETA), and the overall satisfaction scores were 31.8 (VenaSeal™) and 32.1 (ETA). For VenaSeal™ versus surgical stripping, the peri-procedural scores were 29.3 (VenaSeal™) and 25.0 (surgical stripping), and the overall satisfaction scores were 30.1 (VenaSeal™) and 28.3 (surgical stripping). Regarding how much of the vein was treated during the procedure, the reported data shows 92.4% for VenaSeal™ and 91.1% for ETA, and 69.9% for VenaSeal™ versus 68.2% for surgical stripping. No outcome data was reported for the separate venous leg ulcer group in the structured results provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT06391177 · results posted 25 March 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 15 breastfeeding participants in total — 5 in a group taking vonoprazan 20 mg once a day, and 10 in a group taking vonoprazan 20 mg twice a day. All 15 participants completed the study. The trial was measuring how much of the medicine vonoprazan passes into breast milk, by tracking its concentration in breast milk at various points over a 24-hour period. The reported data shows several concentration measurements from breast milk samples. For the once-daily group, the total amount of drug detected in breast milk over 24 hours (a measure called AUC0–24, which captures how much drug was present across the whole day) was 179 ng•h/mL, compared to 317 ng•h/mL in the twice-daily group. The peak (highest) concentration recorded in breast milk was 20.9 ng/mL for the once-daily group and 24.7 ng/mL for the twice-daily group. The lowest recorded concentration was 1.82 ng/mL and 6.78 ng/mL respectively, and the average concentration across the day was 7.55 ng/mL and 13.3 ng/mL. In both groups, the peak concentration in breast milk was reached at around 1.9 hours after the morning dose. As a secondary measure, the reported data shows the estimated total amount of vonoprazan actually excreted into breast milk over 24 hours was very small — 0.00241 mg for the once-daily group and 0.00904 mg for the twice-daily group. These figures represent measurements of how the drug appeared in breast milk under the conditions of this small study, and no comparison to a placebo or control group was included in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01869491 · results posted 13 March 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,107 people in total — 552 in the sodium alginate chewable tablet group and 555 in the placebo (dummy tablet) group. The trial ran for 7 days and was measuring changes in symptoms of heartburn and acid reflux (also called gastro-oesophageal reflux disease, or GERD). Participants filled in a standardised questionnaire called the Reflux Disease Questionnaire (RDQ), which uses a scoring system to capture how often and how badly they experienced heartburn, acid regurgitation, and indigestion-like symptoms. Lower scores on this questionnaire indicate fewer or less severe symptoms. By the end of the study, 531 participants in each group had completed the trial. The reported data shows that the primary measure — the combined heartburn and regurgitation score (rated on a scale of 0 to 40) — fell by 1.27 points in the alginate tablet group and by 1.06 points in the placebo group, both measured from where each group started at the beginning of the trial. For the secondary measures, the reported data shows the indigestion symptom score (scale 0–20) dropped by 0.98 points in the alginate group and 0.80 in the placebo group; the heartburn score alone (0–20) dropped by 1.16 versus 0.95; and the regurgitation score alone (0–20) dropped by 1.37 versus 1.16. In short, both groups showed reductions in their scores over the 7 days, with the alginate group showing slightly larger reductions across all measures. The reported data also shows participants rated their own satisfaction with symptom changes and how important those changes felt to them, though the full breakdown of those satisfaction responses across all rating categories was not completely reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03366012 · results posted 8 November 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03366012) involved 51 participants, all of whom completed the study with no drop-outs. The trial was looking at a device called the Cytosponge — a capsule attached to a string that, when swallowed, expands into a small sponge and collects cells from the food pipe (oesophagus) as it is pulled back out. The study was measuring how many eligible people were willing to try the test, how comfortable the test felt, and whether it could identify signs of a condition called Barrett's oesophagus (where the lining of the food pipe changes in a way that can be detected under a microscope). The reported data shows that 58.6% of eligible patients who were offered the Cytosponge test agreed to go ahead with it. For the tolerability outcome — which asked participants to rate their discomfort on a scale of 1 (no discomfort) to 10 (severe discomfort) after the procedure — no numerical results were reported in the submitted data. Similarly, the result for how accurately the test identified Barrett's oesophagus (known as the positive predictive value) was also not reported in the submitted data. On the safety-related measures, the reported data shows that zero study-related adverse events (unwanted medical occurrences) and zero serious adverse events were recorded among participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05366738 · results posted 29 March 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 27 adults in total, divided into three groups of nine people, each receiving the three study treatments in a different order. The trial was measuring how the body absorbs and processes vonoprazan — a medicine used for stomach acid-related conditions — depending on how it was taken: as a sprinkle capsule mixed into pudding, as a sprinkle capsule mixed into applesauce, or as a standard tablet. The key things being measured were how much of the medicine got into the bloodstream and how quickly it reached its highest level. One participant did not complete the study; the reported data does not explain why. The reported data shows that the three ways of taking vonoprazan produced broadly similar numbers across all the main measurements. The total amount of the medicine that entered the bloodstream over time (a measure called "area under the curve") was reported as 228, 216, and 219 units (ng·h/mL) for pudding, applesauce, and tablet respectively — with similar figures when measured out to a longer time point (238, 227, and 231 units). The peak level of medicine measured in the blood was 23.1, 22.4, and 22.3 ng/mL for pudding, applesauce, and tablet in that order. All three methods reached that peak level at almost the same time — around 2 hours after taking the dose. The time it took for the medicine's level in the blood to fall by half was approximately 7.5, 7.2, and 7.3 hours respectively. The reported data also shows that the rate at which the body cleared the medicine was 83.9, 88.1, and 86.6 litres per hour for pudding, applesauce, and tablet respectively — again, closely comparable figures across all three methods of administration. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04301986 · results posted 8 May 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04301986) enrolled 24 participants, all of whom completed the study. The trial was looking at how people felt about three different procedures used to examine the oesophagus (the tube connecting your throat to your stomach): swallowing a small capsule on a string called a Cytosponge, a thin flexible camera passed through the nose called Transnasal Endoscopy (TNE), and a standard camera procedure done under sedation called an Esophagogastroduodenoscopy (EGD). The study measured things like emotional distress after the procedures, pain or discomfort during them, and which procedure participants said they would prefer to have again. The reported data shows that on a distress scale ranging from 0 to 75 (where higher numbers mean more distress), scores seven days after the EGD were low across all three procedures — 1.42 for the EGD group, 1.21 for the Cytosponge, and 0 for the TNE. On the pain scale, which runs from 0 ("no pain at all") to 100 ("worst pain imaginable"), the reported scores during the procedures were 14.69 for EGD, 49.57 for Cytosponge, and 5.5 for TNE. When asked seven days later whether they would be willing to repeat their procedure, all 24 participants said yes for both the EGD and TNE, while 21 out of 24 said yes for the Cytosponge (3 said no). When asked which single procedure they would prefer to have again, the reported data shows 17 participants chose one option, 6 chose another, and 1 chose the third — however, the labels linking these numbers to specific procedures were not clearly reported in the data, so those details cannot be confirmed here. Regarding what influenced people's preferences, the reported data shows discomfort or pain was selected by 13 participants, sedation by 12, time by 6, cost by 4, and another factor by 3, though participants could choose more than one reason. Ranking scores for preferred procedure were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03193216 · results posted 8 March 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03193216) involved two groups of people with a condition called Barrett's Oesophagus — a change in the lining of the food pipe that can sometimes be associated with a risk of further changes over time. One group of 24 people received a combination of a standard acid-reducing medicine (called a PPI) together with a liquid alginate solution (a seaweed-derived substance sometimes used to coat the stomach). This group was compared against a historical control group of 21 people who had previously been treated with the PPI medicine alone. The trial was measuring whether participants achieved complete removal of the abnormal tissue, as seen through a camera procedure, within 18 months, and how many treatment sessions were needed to get there. The reported data shows that, for the removal of the most abnormal (dysplastic) tissue, 45.5% of people in the alginate group and 38.1% of people in the historical control group were recorded as achieving this outcome. For the complete removal of all abnormal tissue (both dysplastic and non-dysplastic), the reported figures were 36.4% in the alginate group and 19.04% in the historical control group. It is worth noting that 10 of the 24 people in the alginate group did not complete the study, while all 21 in the historical control group did. Regarding the number of treatment sessions, the reported data shows the alginate group received an average of 3.1 sessions to address the most abnormal tissue (compared to 3.88 in the control group), and an average of 3.75 sessions for complete tissue removal (compared to 5 in the control group). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02699060 · results posted 18 February 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 68 participants, all of whom had a condition called GERD (gastro-oesophageal reflux disease, where stomach contents flow back up into the oesophagus). All 68 participants completed the study with none dropping out. The trial was measuring the number of reflux episodes — moments when stomach contents travel back up — in three different sub-groups of GERD patients: those with Non-Erosive Reflux Disease (NERD, where there is no visible damage to the oesophagus), those with Erosive Oesophagitis (EE, where there is visible irritation), and those with Barrett's Oesophagus (BE, a change in the lining of the oesophagus). The reported data shows the average number of reflux episodes recorded for each group, though it is worth noting the results data as submitted lists two sets of measurements per group, which may represent two different types of reflux measured (acid and weakly acid, as described in the study). For the first set of measurements, the NERD group had an average of 33.6 episodes, the EE group had 42.8 episodes, and the BE group had 81.0 episodes. For the second set of measurements, the NERD group recorded 53.1 episodes, the EE group recorded 34.4 episodes, and the BE group recorded 31.8 episodes. No further breakdown or explanation of what distinguishes these two sets of figures was provided in the submitted data, so a fuller interpretation of these numbers is not possible from the information reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03561883 · results posted 18 August 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 609 people in total — 305 in a group receiving a placebo (a dummy treatment) twice daily alongside standard acid-reducing medicines called PPIs (proton pump inhibitors), and 304 in a group receiving 1,500 mg of a medicine called IW-3718 twice daily alongside the same PPIs. The trial was measuring changes in heartburn symptoms over 8 weeks, using a scoring system where participants rated their heartburn severity each day on a scale from 0 (no symptoms) to 5 (severe). Around 520 of the 609 participants completed the study. The reported data shows that, for the main thing being measured — the change in weekly heartburn scores from the start of the trial to week 8 — both groups recorded a reduction in their scores. The placebo-plus-PPIs group had an average reduction of 1.751 points, while the IW-3718-plus-PPIs group had an average reduction of 1.814 points (where a larger reduction means fewer or less severe symptoms were reported). For the secondary measures, the reported data shows similarly close results between the two groups: scores for regurgitation (liquid or food moving back up toward the throat) fell by an average of 1.278 points in the placebo group and 1.287 points in the IW-3718 group. When looking at how many participants had a meaningful reduction in heartburn across the 8 weeks, 41.3% in the placebo group and 42.6% in the IW-3718 group met that threshold. The proportion of days on which participants reported being completely heartburn-free was 0.200 (roughly 1 in 5 days) in the placebo group and 0.234 (roughly 1 in 4 days) in the IW-3718 group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03561090 · results posted 18 August 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03561090) enrolled 495 adults who had ongoing heartburn symptoms despite already taking a standard acid-suppressing medicine called a proton pump inhibitor (PPI). Participants were randomly split into two groups: one group (246 people) received a dummy tablet (placebo) twice a day alongside their PPI, and the other group (247 people) received a medicine called IW-3718 (1500 mg) twice a day alongside their PPI. The trial ran for 8 weeks and was primarily measuring changes in heartburn severity, scored using a diary-based rating scale where higher numbers mean worse symptoms. The reported data shows that for the main outcome — the change in weekly heartburn severity scores after 8 weeks — both groups showed a reduction (improvement) from their starting scores. The placebo group's score dropped by an average of 1.774 points, while the IW-3718 group's score dropped by an average of 1.719 points. For the secondary outcomes, the reported data shows similarly close results between the two groups: the reduction in regurgitation scores was 1.330 for the placebo group and 1.294 for the IW-3718 group; about 53.1% of placebo participants and 47.6% of IW-3718 participants met the definition of an "overall heartburn responder" (meaning their symptoms dropped by 45% or more for at least half the study weeks); and the proportion of completely heartburn-free days was 0.232 for the placebo group and 0.218 for the IW-3718 group. Across all outcomes reported, the numbers for the IW-3718 group were similar to, or slightly lower than, those for the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03020550 · results posted 15 January 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 24 people in total — 8 in the "Standard Visit" group and 16 in the "Expanded Visit" group. All 24 participants completed the study. The trial was measuring body signals during a doctor's visit — specifically, skin electrical activity (called galvanic skin response, or GSR) and heart rate patterns (called heart rate variability, or HRV) — to see whether changes in those signals during the visit were linked to the severity of heartburn and reflux (GERD) symptoms reported by patients two weeks later. It also looked at whether the doctor and patient's body signals moved in a similar pattern together during the visit, and whether that was connected to symptom changes. The reported data shows the following numbers. For skin electrical activity (GSR), the average change during the visit was −0.94 units in the Standard Visit group and −1.70 units in the Expanded Visit group (measured in micro-Siemens). For heart rate patterns (HRV), the average change was −0.26 milliseconds in the Standard Visit group and +2.5 milliseconds in the Expanded Visit group. The degree to which the doctor's and patient's skin signals moved together was reported as an index value of −0.054 in the Standard Visit group and +0.199 in the Expanded Visit group (where a value above zero means the signals were in sync more than half the time). For reflux symptom severity two weeks after the visit (scored 0–12, with higher meaning worse), the reported averages were 3.77 in the Standard Visit group and 2.41 in the Expanded Visit group. Finally, when looking at how much symptoms changed from before to after the visit, the Standard Visit group showed an average increase of 10.3%, while the Expanded Visit group showed an average decrease of 12.2%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03014453 · results posted 26 March 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 187 extremely premature babies who had been diagnosed with bronchopulmonary dysplasia (BPD) — a lung condition that can develop in babies born very early. Of the 187 who started the study, 116 completed it, while 71 did not finish. The trial followed these infants over their first year of life (adjusted for how early they were born) and tracked a range of health complications using questionnaires completed at 3, 6, 9, and 12 months. The reported data shows the number of infants who experienced various complications during the follow-up period. According to the results reported on ClinicalTrials.gov, 57 participants experienced respiratory symptoms (such as needing breathing support at home, taking respiratory medicines, persistent coughing, or being re-admitted to hospital for breathing-related reasons), 45 experienced vomiting during feeding, 30 experienced a type of brain injury related to reduced oxygen supply, and 31 experienced re-hospitalisation for any reason. The data also reports that 4 infants developed retinopathy of prematurity (an eye condition linked to premature birth) and 1 infant experienced sudden death. It is important to note that the results as submitted present these figures together across timepoints rather than broken down separately for each follow-up visit. The reported data does not include a comparison group, so these numbers reflect only the single group of extremely premature infants with BPD who participated in this study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02552966 · results posted 26 February 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 20 participants in a single group, referred to as "UESAD." Of those, 15 people completed the study and 5 did not finish. The trial was measuring levels of a substance called pepsin in saliva — pepsin is a digestive enzyme that is normally found in the stomach — as well as several symptom scores related to reflux and respiratory (breathing and throat) symptoms. The reported data shows that the average pepsin concentration in saliva across participants was 158.4 ng/mL (nanograms per millilitre, a measure of how much of the substance was present). For the secondary measures, the reported average score on the Respiratory Symptom Index (RSI) — a questionnaire where higher numbers out of 45 indicate more severe symptoms — was 19.4. The average score on the GerdQ — a reflux symptom questionnaire scored out of 12, where higher means more severe — was 8.6. The average score on the NGSSIQ questionnaire — another symptom scale — was 26.8. It is worth noting that the data as reported does not include a comparison group or before-and-after figures, so these numbers represent a single snapshot across the group at the time of measurement. It is also worth noting that because only one group was studied, the reported results do not include a comparison to a control or placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02637557 · results posted 15 October 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02637557) enrolled 282 adults across four groups to test a drug called IW-3718 for heartburn. Participants were randomly assigned to take either a dummy pill (placebo) or one of three doses of IW-3718 — 500 mg, 1,000 mg, or 1,500 mg — twice a day for 8 weeks. The main thing being measured was how much participants' weekly heartburn severity scores changed over the course of the trial. Heartburn severity was tracked daily using a 0–5 scale (where 0 meant no heartburn and 5 meant severe), and a lower score over time indicated a reduction in reported severity. The reported data shows that by Week 8, heartburn severity scores had fallen across all four groups. The placebo group's score dropped by about 46%, while the three IW-3718 groups dropped by approximately 49% (500 mg), 55% (1,000 mg), and 58% (1,500 mg). Similar patterns were seen at Week 4. When looking at who counted as an "overall responder" — meaning their weekly heartburn scores dropped by at least 30% for at least half the treatment weeks — the reported figures were 54% of the placebo group, 52% in the 500 mg group, 62% in the 1,000 mg group, and 66% in the 1,500 mg group. The reported data also shows that during Week 8, the percentage of participants who had at least one day with no more than very mild heartburn was 29% (placebo), 18% (500 mg), 30% (1,000 mg), and 38% (1,500 mg). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02135107 · results posted 19 November 2018
According to the results reported on ClinicalTrials.gov, this trial looked at a stomach acid medication called rabeprazole in people with a condition involving inflammation of the oesophagus (the tube connecting your mouth to your stomach). The trial had two main stages. In the first stage, 437 people received rabeprazole 10 mg twice daily and 80 received 20 mg twice daily. Those who responded then moved into a second, maintenance stage, where 178 people were switched to a lower dose of 10 mg once daily and 181 continued on 10 mg twice daily. The trial was mainly measuring how many people had no return of their oesophagus inflammation after 52 weeks, checked by a camera examination (endoscopy). The reported data shows that at the 52-week mark, 44.8% of people in the once-daily maintenance group showed no return of inflammation, compared with 73.9% in the twice-daily maintenance group. At earlier check-ins, the reported data shows that 62.5% (once daily) versus 92.4% (twice daily) had no return at 12 weeks, and 55.8% versus 85.1% at 24 weeks. A separate calculation using a standard statistical method (which estimates how results accumulate over time) put the 52-week non-recurrence figures at 41.5% and 71.4% for the once-daily and twice-daily groups respectively. The reported data also includes information about heartburn symptoms during the maintenance period. Among participants who had no heartburn at the start of that stage, 23.2% in the once-daily group and 8.0% in the twice-daily group were reported to have experienced heartburn at some point during maintenance. In both groups, the large majority of heartburn episodes that did occur were recorded as mild in severity — around 85% of participants in each group reported no heartburn symptoms at their assessments. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02200055 · results posted 28 August 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 86 participants, all of whom completed the study with no drop-outs. The trial was measuring something called **bioimpedance** — a technique that passes a tiny electrical signal through the body to estimate how fluid is distributed across different body compartments. Measurements were taken at three points: before a surgical procedure, six hours after the procedure, and across the broader postoperative (after surgery) period. The trial also tracked how fluid was split between the spaces inside and outside the body's cells. The reported data shows that the bioimpedance readings (measured in ohms, a unit of electrical resistance) were 0.53 ohms before surgery, 0.57 ohms at six hours after surgery, and an average of 0.59 ohms across the postoperative period overall. For the secondary measurements relating to body fluid distribution, the reported figures show extracellular water (fluid outside the cells) was recorded at 0.89% of total water volume before surgery and 0.32% of total water volume at six hours after surgery. Intracellular water (fluid inside the cells) was recorded at 0.82% of total water volume at six hours after surgery. It is worth noting that the reported percentage figures appear unusually low compared to typical ranges, and no further explanation for this was provided in the submitted data. The reported data does not include any additional context about what these numbers mean clinically, and no comparison group (such as a control or placebo group) was included in this trial's results as submitted. If any other outcome data was collected, it was not reported on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00388453 · results posted 27 June 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 47 people across three groups: 20 healthy volunteers with no history of reflux or acid-suppressing medication use, 17 people with a history of gastro-oesophageal reflux disease (GORD — a condition where stomach acid regularly flows back into the food pipe), and 10 people with laryngopharyngeal reflux (LPR — a condition where stomach acid travels all the way up to the throat). All 47 participants completed the study with no dropouts reported. The trial measured acid levels at two locations — the lower food pipe and the throat — at the same time, using specially designed probes, to track how often and for how long acid levels dropped below certain thresholds in each group. The reported data shows the percentage of total monitoring time that acid levels in the lower food pipe fell below three different thresholds. For the healthy volunteer group, acid fell below a pH of 4 for 1.1% of the time, below pH 5 for 3.0% of the time, and below pH 6 for 11% of the time. For the GORD group, the reported figures were 3.2%, 6.5%, and 29% respectively. For the LPR group, the figures were 3.8%, 13%, and 31% respectively. In plain terms, pH is a measure of acidity — the lower the number, the more acidic; so these figures describe how much of the monitoring period involved more strongly acidic conditions in the food pipe. The reported data also shows a secondary measurement: the number of individual reflux events (defined as an acid drop lasting more than five seconds, not during meals) recorded in the lower food pipe. The healthy volunteer group had an average of 6.5 such events, the GORD group had 102 events, and the LPR group had 75 events. No figures for the throat (oropharyngeal) measurements were included in the submitted results data, so those numbers were not reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00444145 · results posted 29 March 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT00444145) enrolled 38 participants, all of whom received a medication called Prevacid (lansoprazole). The trial was looking at a specific physical change in the cells lining the oesophagus (the tube connecting the mouth to the stomach) called "dilation of intracellular spaces." In simple terms, this refers to whether the tiny gaps between cells in the oesophagus lining had become enlarged — something researchers consider a possible early structural sign of gastro-oesophageal reflux (where stomach acid travels back up into the oesophagus). This measurement was taken using a powerful microscope technique called electron microscopy, three months after participants received the treatment. The reported data shows that of the 38 people who started the trial, 19 completed it and 19 did not complete it — the reasons for not completing were not detailed in the data provided. For the primary outcome measure — the number of participants who still showed enlarged intracellular spaces at the three-month mark — the reported result was zero participants. No secondary outcome measures were included in the submitted results data, so no further figures are available to describe. It is worth noting that this trial had only one group (everyone received Prevacid), so there was no comparison group reported in this data. Any interpretation of what the numbers mean would require discussion with a qualified health professional. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00911534 · results posted 2 February 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 300 people in total — 147 in the placebo group (a dummy treatment with no active ingredient) and 153 in the group taking a 50 mg extended-release form of rabeprazole (RAB ER 50mg), a medicine used for acid-related stomach and oesophagus conditions. The trial was measuring symptoms of gastro-oesophageal reflux disease (GORD — commonly known as acid reflux), particularly heartburn, over a four-week period. Participants kept a daily diary recording their symptoms. By the end of the study, 132 people in the placebo group and 137 in the RAB ER 50mg group had completed the trial. The reported data shows that the main thing being measured was the percentage of days during the four weeks on which participants recorded no heartburn at all. For the placebo group, that figure was reported as 21.23% of days, compared with 41.14% of days for the RAB ER 50mg group. The reported data also shows changes in the average daily severity score for reflux-related symptoms (rated on a 0–4 scale, where 0 means no symptom and 4 means very severe). For daytime heartburn, the placebo group's score changed by −0.82 and the RAB ER 50mg group's by −1.22; for nighttime heartburn, the changes were −0.74 and −1.17 respectively; and for regurgitation, −0.49 and −0.74. In addition, the proportion of participants who had complete heartburn relief was reported as 3.4% (placebo) versus 15% (RAB ER 50mg) at one time point, and 7.5% versus 22.2% at another — though the specific time points for these two measurements were not clearly labelled in the submitted data. The reported median time to the first full 24-hour period without any heartburn was 14.4 days for the placebo group and 10.6 days for the RAB ER 50mg group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00839306 · results posted 16 November 2015
According to the results reported on ClinicalTrials.gov, this trial compared two treatments for erosive gastro-oesophageal reflux disease (eGERD) — a condition where stomach acid causes sores in the oesophagus (the tube connecting your mouth to your stomach). One group received a medicine called ranitidine (RAN) at 150mg twice a day, and the other received rabeprazole extended-release (RAB ER) at 50mg once a day. A total of 60 people started in the ranitidine group and 177 in the rabeprazole group. By the end of the study, 35 people in the ranitidine group and 134 in the rabeprazole group had completed it. The reported data shows that the main thing the trial measured was how many participants still had complete healing of their oesophageal sores at 26 weeks. According to the results reported on ClinicalTrials.gov, 31.7% of participants in the ranitidine group still had complete healing at that point, compared to 88.4% in the rabeprazole group. The trial also measured sustained resolution (ongoing absence) of heartburn symptoms at 26 weeks as a secondary outcome. The reported data shows that 8.3% of the ranitidine group and 53.7% of the rabeprazole group had this outcome recorded. Additional symptom breakdown figures were also reported, though the specific categories those remaining numbers correspond to were not clearly labelled in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00734747 · results posted 14 August 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 72 participants who all received a procedure using a device called the Medigus SRS Endoscopic Stapling System — a type of internal stapling tool used through the throat (an endoscope) to treat gastro-oesophageal reflux disease (GORD), commonly known as acid reflux. The trial was measuring whether the procedure led to improvements in participants' reflux-related quality of life, as well as tracking serious unwanted events and changes in acid levels and medication use over six months. Of the 72 people who started, 66 completed the full six-month follow-up period. The reported data shows that 73% of participants had at least a 50% improvement in their reflux symptom score (a questionnaire-based measure of how much reflux affected daily life) when measured six months after the procedure and while not taking their usual reflux medication. Regarding serious adverse events — meaning significant unwanted medical occurrences — the data reports these in two groups due to a mid-trial review: 8 serious adverse events occurred among the first 24 participants, and 2 occurred among the final 48 participants. On the acid monitoring test (which measures how often stomach acid reached the oesophagus), the reported average figure at six months was 7.3% of the monitored time, though the data does not include the pre-procedure comparison figure for direct reference here. The reported data also shows figures related to participants' use of reflux medication (proton pump inhibitors, or PPIs — tablets that reduce stomach acid): 65% of participants reported reducing their PPI use, and 85% reported a separate measure of PPI-related change, though the data does not provide further labels distinguishing these two figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00658775 · results posted 23 June 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,065 adults in total — 537 in one group taking esomeprazole 40mg (ESO 40mg) and 528 in another group taking rabeprazole extended-release 50mg (RAB ER 50mg). The trial was looking at people with a condition called erosive gastro-oesophageal reflux disease (eGERD) — a form of reflux where the lining of the food pipe has visible damage (erosions). The main things being measured were how many participants showed healing of those erosions (confirmed by a camera examination of the food pipe) at 4 weeks and again at 8 weeks, as well as how many participants went at least 7 days in a row without heartburn during the first 4 weeks. The reported data shows that for healing confirmed by camera at 4 weeks, around 50.7% of the ESO 40mg group and 50.9% of the RAB ER 50mg group showed healing. By 8 weeks, those figures rose to 78.4% in the ESO 40mg group and 77.5% in the RAB ER 50mg group. For the heartburn diary measure — achieving at least 7 consecutive heartburn-free days within the first 4 weeks — the reported data shows 52.5% of the ESO 40mg group and 53.2% of the RAB ER 50mg group reached that point. Of the participants who started the trial, 495 in the ESO 40mg group and 485 in the RAB ER 50mg group completed it. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00658632 · results posted 23 June 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,380 people in total — 682 were given esomeprazole (ESO) 40 mg and 698 were given rabeprazole extended release (RAB ER) 50 mg. Both are medicines commonly used for acid-related stomach conditions. The trial was measuring whether either medicine could heal damage to the lining of the food pipe (called erosive gastro-oesophageal reflux disease, or eGERD), confirmed by a camera examination of the food pipe (an endoscopy), at 4 weeks and again at 8 weeks. It also measured whether participants went at least 7 days in a row without heartburn during the first 4 weeks, as recorded in a daily diary. The reported data shows that for the main (primary) goals, at the 4-week endoscopy check, 75.3% of participants in the ESO group and 75.9% in the RAB ER group showed healing. By the 8-week check, those figures rose to 87.8% in the ESO group and 88.2% in the RAB ER group. For the secondary goal — going 7 or more consecutive days without heartburn by week 4 — the reported data shows this was recorded in 38.5% of the ESO group and 41.9% of the RAB ER group. The reported data also includes some participants whose results fell into different healing categories or who did not have a result recorded, though the breakdown of those figures is part of the full dataset on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00658528 · results posted 23 June 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,055 people in total — 531 in one group who took esomeprazole 40 mg (ESO 40 mg), and 524 in another group who took a different medication, rabeprazole extended-release 50 mg (RAB ER 50 mg). The trial was looking at adults with a condition called erosive gastroesophageal reflux disease (eGERD) — a form of reflux where the lining of the food pipe shows visible damage (erosions). The main things being measured were how many participants' food pipe damage had visibly healed (confirmed by a camera examination called an endoscopy) at 4 weeks and again at 8 weeks, as well as how many participants went at least 7 days in a row without heartburn during the first 4 weeks. The reported data shows that for the primary (main) outcomes, at the 4-week endoscopy check, 50.3% of the ESO 40 mg group and 54.8% of the RAB ER 50 mg group showed confirmed healing of their food pipe damage. By 8 weeks, those figures were 75% in the ESO 40 mg group and 80% in the RAB ER 50 mg group. For the secondary (additional) outcome — achieving 7 or more consecutive heartburn-free days by week 4 — the reported data shows 48.2% in the ESO 40 mg group and 48.3% in the RAB ER 50 mg group reached that point. It is worth noting that the data as submitted includes multiple sets of measurements per outcome (likely reflecting different subgroups or timepoints), but not all labels for those breakdowns were included in the structured data provided, so a full breakdown cannot be described here. Overall, 491 participants in the ESO group and 479 in the RAB ER group completed the trial, with 40 and 45 respectively not completing it; reasons for non-completion were not reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01990339 · results posted 11 November 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 14,965 people, all of whom received a medicine called lansoprazole. There was only one group in this study — no comparison or placebo group. Of those who started, 12,653 completed the trial, while 2,312 did not finish. The trial was measuring two main things: how much participants' stomach-related symptoms improved after four weeks of taking the medicine, and how often unwanted health events (called adverse events) were recorded during that time. The reported data shows that the primary outcome — symptom improvement — was measured across nine different individual symptoms. For each symptom, investigators rated whether it had "disappeared" or "improved" and combined those two categories into a single improvement figure. The reported improvement rates across the nine symptoms ranged from around 61.6% to 75.7% of participants. The specific symptoms linked to each of these percentages were not clearly labelled in the data provided to ClinicalTrials.gov, so it is not possible to say which percentage belongs to which symptom. For the secondary outcome, the reported data shows that adverse events (unwanted health occurrences recorded during the study) were tracked across twelve categories. The percentages of participants who experienced each type of adverse event were very small, ranging from 0.02% to 0.69%. Again, the specific names of each adverse event type were not included in the structured data reported, so the individual figures cannot be matched to named events here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01642602 · results posted 6 August 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT01642602) enrolled 104 adults who were given dexlansoprazole 30 mg, a medication used for heartburn. Of those, 102 people completed the four-week treatment period, and 2 did not finish. The trial was looking at two things: what unwanted health events (called adverse events — meaning any health problems that appeared or got worse after starting the medication) occurred in at least 5% of participants, and how often participants experienced days completely free of both daytime and nighttime heartburn. The reported data shows that two types of adverse events were each experienced by approximately 6.7% of participants during the four-week treatment period — though the specific names of those events were not included in the data provided here. Regarding heartburn-free days, the reported data shows that participants recorded having no heartburn at all (neither during the day nor at night) on an average of 47.3% of days across the four weeks of treatment. No other outcome figures were reported in the data available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01472939 · results posted 15 April 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 480 people in total across four groups. Participants were experiencing ongoing reflux symptoms (such as regurgitation and heartburn) despite already taking a common acid-reducing medicine called a proton pump inhibitor (PPI). The trial was testing whether adding different doses of an investigational medicine called SSP-002358 (at 0.1 mg, 0.5 mg, or 2.0 mg) to a PPI made any difference compared to adding a placebo (a dummy pill) to a PPI. The main thing the trial measured was the change in the percentage of days participants were free from regurgitation during weeks 5 to 8 of the study. The reported data shows that, for the main outcome, the placebo group saw an average increase of around 37 percentage points in regurgitation-free days, while the three SSP-002358 groups saw increases of approximately 43, 44, and 39 percentage points for the 0.1 mg, 0.5 mg, and 2.0 mg doses respectively. For the secondary outcome of heartburn-free days, the reported increases were around 22 percentage points for the placebo group and approximately 29, 31, and 27 percentage points for the three SSP-002358 doses. A symptom questionnaire called the PRISM score (where lower numbers mean fewer or less severe symptoms) also showed reductions across all groups — roughly 13 points for placebo and between 15 and 16 points for the SSP-002358 groups. The trial also measured how much of the study drug entered the bloodstream at each dose, and the reported data shows that higher doses were associated with higher drug levels in the blood, which is what would generally be expected. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00131248 · results posted 15 January 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 18 people in total — 9 in each of two groups. It used a "crossover" design, meaning that over the course of the study each participant took part in multiple rounds: some periods involved taking active medications and others involved taking a placebo (a dummy treatment with no active ingredient). There were three intervention periods separated by short 24-hour washout breaks (rest periods where no treatment was given). The trial was measuring episodes of bradycardia — a medical term for the heart beating more slowly than normal — counting how many of these episodes occurred per day. The reported data shows that the primary outcome measured was the average number of bradycardia episodes per day. According to the results reported on ClinicalTrials.gov, participants recorded an average of 4.6 episodes per day during the medication periods, compared with 3.6 episodes per day during the placebo periods. No other outcome measures appear to have had their results submitted — the data was not reported for any secondary outcomes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00992589 · results posted 22 May 2013
According to the results reported on ClinicalTrials.gov, this trial involved infants being assessed for symptoms associated with gastro-oesophageal reflux (where stomach contents flow back up into the food pipe). The trial ran in two stages. In the first, open-label stage — where everyone knew what was being given — 344 infants received rabeprazole sodium 10 mg, and 267 of them went on to complete that phase. In the second, double-blind stage — where neither the families nor the researchers knew which treatment each baby was receiving — 267 of those infants were divided into three groups: 89 received a placebo (a dummy treatment with no active ingredient), 90 received rabeprazole sodium 5 mg, and 88 received rabeprazole sodium 10 mg. The trial measured changes in how often regurgitation (spitting up) occurred each day, changes in the infants' weight relative to other babies their age and sex, and caregiver-reported scores on a daily diary questionnaire about regurgitation, discomfort, and eating behaviour. The reported data shows that for the main (primary) outcome — the change in average daily regurgitation frequency during the double-blind phase — the placebo group and the 5 mg group each recorded a change of −0.8 episodes per day, while the 10 mg group recorded a change of −1.6 episodes per day (a negative number meaning fewer episodes compared to the start of this phase). For weight gain relative to other babies of the same age and sex (measured using a standard scoring system called a Z-score, where a higher number means closer to the typical range), all groups showed small increases: +0.11 in the placebo group, +0.16 in the 5 mg group, and +0.11 in the 10 mg group. For the secondary outcomes, the caregiver diary scores for regurgitation, discomfort, and eating behaviour all showed small reductions (improvements) across all groups, including the placebo group, with changes generally ranging from 0.0 to −1.0 points on their respective scales. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00394472 · results posted 18 March 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 244 people in total — 122 in the AZD3355 group and 122 in the placebo (dummy treatment) group. The trial was looking at a drug called AZD3355 compared to a placebo, and was measuring symptoms of reflux — specifically "a burning feeling behind the breastbone" (heartburn) and "unpleasant movement of material upwards from the stomach" (regurgitation). Participants rated these symptoms twice a day using a diary with a six-level scale ranging from "Did not have" through to "Severe." Most participants completed the trial: 113 in the AZD3355 group and 111 in the placebo group. The reported data shows that the main thing being measured was how many participants had no more than one day where their symptoms were rated at "mild" or better (that is, very mild or not present at all) during the final seven days of treatment. According to the results reported on ClinicalTrials.gov, 17 out of 122 participants in the AZD3355 group met this measure, compared with 8 out of 122 participants in the placebo group. A secondary measurement recorded the level of AZD3355 in the blood one to two hours after the first dose was taken; the reported data shows an average level of 0.96 µmol/L (micromoles per litre, a standard unit for measuring how much of a substance is in the blood) for those who received AZD3355. No blood concentration data was reported for the placebo group, which is expected as that group did not receive the drug. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00444275 · results posted 11 December 2012
According to the results reported on ClinicalTrials.gov, this trial involved people with reflux-related symptoms and was run in two stages. In the first stage (the "initial phase"), a total of 2,156 people were assigned to a lower dose of esomeprazole (20 mg once daily) and 873 to a higher dose (40 mg once daily). Those who completed the initial phase were then moved into a second "maintenance phase," where 908 people continued on esomeprazole 20 mg once daily, 897 took esomeprazole 20 mg "on demand" (meaning only when needed), and 880 were given antacid treatment. The trial was primarily measuring how well each of the three maintenance strategies controlled reflux symptoms over about 12 weeks, as judged by the patients themselves. The reported data shows that, for the main outcome — the proportion of people whose maintenance treatment was considered to have "failed" (meaning they felt their symptoms weren't well enough controlled or they didn't want to continue) — the numbers differed noticeably across the three groups. In the daily esomeprazole 20 mg group, 10.6% of participants were recorded as treatment failures. In the on-demand esomeprazole group, the reported failure rate was 7.8%. In the antacid group, the reported failure rate was considerably higher at 43%. For one secondary measure looking at changes in upper digestive symptom scores during the maintenance phase (on a scale where higher numbers mean less frequent symptoms), the reported changes were small: +0.12 for daily esomeprazole, +0.04 for on-demand esomeprazole, and −0.22 for the antacid group. The reported data also shows that serious or study-stopping unwanted events during the maintenance phase occurred in 5 participants on daily esomeprazole, 4 on on-demand esomeprazole, and 15 in the antacid group. One secondary outcome relating to the impact of low-dose aspirin use could not be meaningfully reported, as only two participants in the trial took aspirin. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00069823 · results posted 19 October 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 402 people with asthma — 199 received a placebo (a dummy treatment with no active ingredient) and 203 received esomeprazole, a medicine commonly used to reduce stomach acid. The trial was investigating whether taking esomeprazole could reduce "episodes of poor asthma control" — that is, periods when asthma worsened, defined by a significant drop in breathing capacity, an urgent medical visit for asthma, or the need to start steroid tablets. Most participants completed the study (193 in the placebo group and 200 in the esomeprazole group). The reported data shows that for the main (primary) outcome — episodes of poor asthma control per person per year — the placebo group recorded 2.3 episodes and the esomeprazole group recorded 2.5 episodes. For the secondary outcomes, the reported figures were also similar between the two groups: urgent care visits (0.6 vs 0.5 events per person per year), new use of steroid tablets (0.6 vs 0.5), large drops in peak breathing flow on two days in a row (1.7 vs 2.1), increased use of reliever (rescue) inhalers (3.0 vs 2.8), and a broader measure of asthma episodes that also counted increased reliever use (4.4 vs 4.3). In each case, the numbers between the two groups were close together. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00734097 · results posted 10 October 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 337 people who were screened for participation, with 317 moving into the treatment phase and 311 included in the main analysis. All participants received a daily 40 mg dose of esomeprazole (a medicine commonly used for acid-related stomach conditions) in an open-label study — meaning everyone knew what they were taking. The trial was measuring changes in how often and how severely participants experienced heartburn and acid regurgitation (the feeling of stomach acid coming back up) over 4 and 8 weeks of treatment. The reported data shows that, for the primary outcome, the frequency of days per week with heartburn changed by an average of −3.44 days per week from the start of the trial to week 8. In plain terms, participants on average reported experiencing heartburn on fewer days per week by the end of the 8-week period. At the 4-week mark, the reported change was −3.08 days per week. For heartburn severity — measured using a questionnaire with scores ranging from 0 (not present) to 5 (severe) — the reported change was −1.34 score points at 4 weeks and −1.56 score points at 8 weeks. For acid regurgitation, the reported change in days per week with symptoms was −2.95 at 4 weeks and −3.28 at 8 weeks. The reported data shows only the average change figures for these outcomes; no other comparison group (such as a placebo or no-treatment group) was included in this trial's design, so these numbers reflect changes from each participant's own starting point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01119768 · results posted 28 September 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 305 people in total — 154 in a group that received 8 weeks of treatment with a medicine called esomeprazole, and 151 in a group that received just 2 weeks of the same medicine. The trial was looking at how well each treatment length controlled symptoms of gastro-oesophageal reflux disease (commonly known as reflux or GERD) — a condition where stomach acid causes discomfort such as heartburn. Symptoms were measured using a questionnaire called GerdQ, and participants were followed up over 24 weeks in total. The reported data shows that at the 24-week mark, 94.9% of participants in the 8-week treatment group had their reflux symptoms controlled according to the GerdQ questionnaire, compared with 87.3% in the 2-week treatment group. When looking at the whole study period, 83.8% of the 8-week group and 72.8% of the 2-week group were counted as "successes" — meaning their symptoms were relieved during treatment and stayed under control during the follow-up period. For symptom relief at the end of each group's treatment course, 88.3% of the 8-week group and 83.4% of the 2-week group met the criteria (no more than one day of mild symptoms in the previous week). The reported data also shows that in the 2-week group, the midpoint at which half of participants experienced a return of symptoms was 57 days after finishing treatment; for the 8-week group, this figure was not able to be calculated because fewer than half of participants in that group had a return of symptoms by the end of the study. Additionally, 59 people in the 8-week group and 80 people in the 2-week group had at least one unscheduled visit to hospital during the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00847210 · results posted 5 October 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 36 adult participants in total — 18 people took a 30 mg once-daily dose of dexlansoprazole MR, and 18 took a 60 mg once-daily dose. All 36 participants completed the study. The trial was not testing whether the medicine relieved symptoms; instead, it was a pharmacokinetic study, meaning it was tracking how the drug moves through the body — how quickly it is absorbed into the bloodstream, how high the concentration gets, and how long it takes to clear out. The reported data shows the following measurements, taken on Day 7 of dosing. For the 30 mg group, the drug reached its peak blood concentration after about 4.65 hours, with a peak level of 691 ng/mL (nanograms per millilitre, a measure of concentration in the blood). For the 60 mg group, peak concentration was reached a little earlier at around 3.31 hours, with a higher peak level of 1,136 ng/mL. The overall exposure to the drug over 24 hours (a measure called AUC, which reflects the total amount of drug in the bloodstream across the day) was reported as 2,886 units for the 30 mg group and 5,120 units for the 60 mg group. The time for half the drug to leave the bloodstream — known as the "half-life" — was reported as approximately 1.66 hours for the 30 mg group and 2.59 hours for the 60 mg group. The rate at which the body cleared the drug was reported as 12.81 litres per hour for the 30 mg group and 15.29 litres per hour for the 60 mg group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00561730 · results posted 16 September 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,995 participants, all of whom received the medication pantoprazole. Of those, 1,986 completed the study and 9 did not. The trial was measuring how participants rated several aspects of their wellbeing over time using a symptom diary tool called ReQuest™ in Practice. Participants scored six different areas — general wellbeing, acid complaints (such as heartburn), upper stomach complaints, lower abdominal or digestive complaints, nausea, and sleep disturbances — at multiple points across the study period. The reported data shows that scores were recorded at seven time points throughout the trial. For general wellbeing, participants used a scale from 0 (excellent) to 10 (extremely bad), and the reported scores moved from 5.31 at the first time point down to 1.91 by the final time point. For acid complaints, scores were recorded on a scale from 0 (none) to 10 (extremely strong), starting at 6.14 and falling to 1.33 by the end. Upper stomach complaints started at 4.73 and reached 1.31, lower abdominal and digestive complaints went from 2.48 to 1.20, nausea scores moved from 3.00 to 1.02, and sleep disturbance scores went from 3.15 to 1.38. In each category, the reported numbers decreased across the seven measurement points. It is important to note that this trial had only one group — there was no comparison group — so the reported figures simply describe how scores changed over time within that single group of participants. No comparison data was reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00464308 · results posted 30 August 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,392 adults across three groups: 464 took rabeprazole 20 mg per day, 469 took esomeprazole 40 mg per day, and 459 took esomeprazole 20 mg per day. The trial was measuring how well each medicine reduced two common acid reflux symptoms — heartburn and regurgitation (the feeling of stomach contents coming back up) — over four weeks. Researchers tracked two levels of improvement: "complete resolution," meaning no symptoms at all for any seven days in a row, and "satisfactory resolution," meaning symptoms stayed absent or only very mild for any seven days in a row. The reported data shows the following for complete resolution of heartburn by week four: 272 out of 464 participants in the rabeprazole group, 302 out of 469 in the esomeprazole 40 mg group, and 278 out of 459 in the esomeprazole 20 mg group. For complete resolution of regurgitation, the numbers were 281, 283, and 276 respectively. When looking at satisfactory resolution (symptoms no worse than mild), the reported figures were higher: for heartburn, 405, 418, and 414 participants across the three groups; and for regurgitation, 397, 413, and 402 participants. The reported data also shows the middle point in time (median — meaning half of participants reached this point sooner, half later) at which complete heartburn resolution occurred: 11 days for rabeprazole, 9 days for esomeprazole 40 mg, and 12 days for esomeprazole 20 mg. For regurgitation, the median times were 9, 11, and 13 days respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00427635 · results posted 19 May 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 52 infants or children, with 26 in each group — one group received esomeprazole (a medicine that reduces stomach acid) and the other received a placebo (a dummy treatment with no active medicine). The trial was measuring signs and symptoms of gastro-oesophageal reflux disease (GORD, sometimes called GERD — where stomach contents flow back up into the oesophagus) observed over an 8-hour video and heart-and-breathing monitoring session, as well as reflux episodes tracked over 24 hours using a special tube that measures acidity. The reported data shows that, for the main outcome — the average change in the number of GORD-related events observed during monitoring — the esomeprazole group showed a reduction of about 28 events from their starting point, while the placebo group showed a reduction of about 25 events. For the secondary outcomes, the esomeprazole group showed an average reduction of about 22 GORD events that were linked to acid reflux, compared to a reduction of about 13 in the placebo group. Looking at overall reflux episodes tracked over 24 hours, the esomeprazole group had an average reduction of about 15 episodes, while the placebo group had an average increase of about 6 episodes. For acid-only reflux episodes, the esomeprazole group had an average reduction of about 38, compared to a small average increase of about 2 in the placebo group. Weakly acidic reflux episodes (those with a mid-range acidity level) showed an average increase of about 23 in the esomeprazole group and about 4 in the placebo group. Non-acidic reflux episodes showed very small average changes in both groups (an increase of about 0.6 and 0.3 respectively). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00362609 · results posted 14 May 2010
According to the results reported on ClinicalTrials.gov, this trial involved 59 infants in total — 19 received a 1.25 mg dose of pantoprazole and 40 received a 2.5 mg dose. All 19 infants in the lower-dose group completed the study, while 38 of the 40 in the higher-dose group completed it (2 did not finish). The trial was measuring how the drug moved through the body in young infants — specifically looking at how much of the drug was absorbed into the bloodstream, how quickly it was cleared, and how long it stayed in the body. The reported data shows that the primary thing being assessed was whether the drug's absorption varied too widely between infants to make further testing meaningful. The reported figures (1.07 for the 1.25 mg group and 0.74 for the 2.5 mg group) were both below the threshold of 1.2 that had been set in advance, suggesting the variation was not considered "highly variable" by the study's own definition. For the secondary measurements, the reported data shows that the amount of drug detected in the blood over time (a measure called "area under the curve") was 3,540 ng·hr/mL for the lower dose and 7,270 ng·hr/mL for the higher dose. The rate at which the body cleared the drug was reported as 0.21 L/hr/kg and 0.23 L/hr/kg respectively, and the time for half the drug to leave the body was reported as 3.1 hours for the lower dose and 2.7 hours for the higher dose. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00259012 · results posted 7 May 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 67 children or young people in total — 33 in a lower-dose group (0.6 mg/kg of pantoprazole) and 34 in a higher-dose group (1.2 mg/kg). Most participants finished the study: 31 completed in the low-dose group and 30 in the high-dose group. The trial was measuring how the body processes pantoprazole — a medicine used for stomach acid conditions — by tracking how the drug moves through the bloodstream after it is swallowed. These measurements are called pharmacokinetic (PK) parameters, which simply means how the drug is absorbed, how long it stays in the body, and how quickly it is cleared away. The reported data shows several key blood-level figures. After a single dose, the peak amount of pantoprazole detected in the blood was 567 ng/mL (nanograms per millilitre, a very small unit of measurement) in the low-dose group and 1,527 ng/mL in the high-dose group. Both groups reached that peak at roughly the same time — about 1 hour after taking the dose. The "half-life" (the time it took for half the drug to leave the body) was reported as 1.78 hours in the low-dose group and 1.42 hours in the high-dose group. The overall exposure to the drug over time (a measure called AUC) was 1,046 units in the low-dose group and 3,602 units in the high-dose group. The rate at which the body cleared the drug was reported as 1.54 L/hr/kg in the low-dose group and 0.87 L/hr/kg in the high-dose group. After multiple doses, pantoprazole blood levels were also measured to check whether the drug built up in the body, with figures of 289 and 69 ng/mL reported at different time points for the low-dose group, and 668 and 353 ng/mL for the high-dose group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00627016 · results posted 6 May 2010
According to the results reported on ClinicalTrials.gov, this trial involved 305 adults — 153 in the placebo group and 152 in the dexlansoprazole 30 mg group — with nearly all participants completing the four-week study (147 and 146 respectively). The trial was measuring nighttime heartburn in people with gastro-oesophageal reflux disease (GORD, a condition where stomach acid repeatedly flows back into the food pipe). Participants kept a daily electronic diary recording whether they experienced heartburn or sleep disturbances overnight, and those records were used to calculate the results. The reported data shows that, looking at the main thing being measured — the middle-point percentage of nights without heartburn across four weeks — participants in the placebo group recorded heartburn-free nights roughly 35.7% of the time, while those in the dexlansoprazole group recorded heartburn-free nights roughly 73.1% of the time. For the additional measures, the reported data shows that in the final week of treatment, about 19.6% of placebo participants and 47.5% of dexlansoprazole participants met the study's definition of "relief" from nighttime heartburn (meaning no more than one mild episode across seven nights). Regarding sleep disturbances linked to GORD, approximately 47.9% of placebo participants and 69.7% of dexlansoprazole participants met the definition of "relief" (meaning no such disturbances on at least six of the final seven nights). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00868296 · results posted 7 January 2010
According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called pantoprazole (a drug used to reduce stomach acid) given to infants. A total of 58 babies took part — 12 received a lower dose and 46 received a higher dose. All 12 in the low-dose group completed the trial, while 43 of the 46 in the high-dose group completed it (3 did not finish). The trial was measuring two main things: whether any blood or urine test results reached levels considered potentially concerning, and how the babies were growing compared to standard growth charts. The reported data shows that, for the blood and urine tests, none of the babies in the low-dose group had any results flagged as potentially concerning, while in the high-dose group, small numbers did — for example, 3 babies had a flagged result for one particular test, 2 for another, and 1 each for several others (with the exception of one test where 1 baby in the low-dose group was flagged and none in the high-dose group). For the growth measurements, the trial used something called a "z-score" — a number that simply shows how a baby's measurements compare to a typical baby of the same age, where 0 means exactly average. The reported data shows that babies in the low-dose group had z-scores close to 0 (near average) across different growth measures, ranging from about -0.16 to +0.45. Babies in the high-dose group had z-scores that were below average, ranging from about -1.63 to -0.62. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00251758 · results posted 23 March 2009
According to the results reported on ClinicalTrials.gov, this trial enrolled 908 people across three groups: 292 received a placebo (a dummy pill with no active ingredient), 312 received a 60 mg daily dose of dexlansoprazole MR, and 304 received a 90 mg daily dose. The majority of participants finished the study — 264, 285, and 277 people respectively. The trial was measuring how often people experienced days completely free of heartburn, both during the day and at night, with participants recording their symptoms each day using an electronic diary. The reported data shows that, for the main measure — the percentage of days with no heartburn at all (day or night) — the middle value (called the "median," meaning the midpoint across all participants) was 17.0% of days for the placebo group, 45.7% for the 60 mg group, and 52.7% for the 90 mg group. When looked at using the average across all participants (the "mean"), the figures were 24.9% for placebo, 44.8% for the 60 mg group, and 49.1% for the 90 mg group. For the secondary measure — nights free of heartburn specifically — the reported median was 51.0% of nights for the placebo group, 72.3% for the 60 mg group, and 76.6% for the 90 mg group. The corresponding averages were 49.6%, 62.0%, and 64.4% respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.