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Reported trial results for Gastroparesis

Every Gastroparesis 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.

36 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

  • NCT05362578 · results posted 20 July 2026

    According to the results reported on ClinicalTrials.gov, this trial (NCT05362578) enrolled 41 people in total — 21 in the treatment group and 20 in a sham (inactive/comparison) group. The trial was looking at a condition called gastroparesis, which affects how the stomach empties food, and measured changes in stomach-related symptoms, quality of life, stomach function, and certain body signals (electrical activity in the stomach and heart) over about 12 weeks. By the end of the study, 15 people had completed the treatment group and 13 had completed the sham group. Notably, 13 of the sham group participants chose to receive the active treatment after the initial 8-week period. The reported data shows that for the main outcome — a symptom score (rated 0 to 4, where higher means worse symptoms) — the treatment group started with an average score of 2.24 and ended at 1.97, while the sham group started at 1.95 and ended at 1.66. For quality of life (scored 0–100, where higher means better functioning), the treatment group went from 43.4 down to 38.5, while the sham group went from 56 down to 52.5. For stomach capacity — measured by how much water participants could comfortably drink — the treatment group went from about 606 mL to 773 mL, while the sham group went from 850 mL to 731 mL. The reported data also shows changes in stomach electrical activity and a heart-based measure of the nervous system, with the treatment group's normal stomach wave percentage going from 52% to 64%, and the sham group from 61% to 61%. The heart nervous system measure (a ratio reflecting certain nerve activity) went from 0.34 to 0.40 in the treatment group, and from 0.40 to 0.44 in the sham 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 ↗

  • NCT04254549 · results posted 22 June 2026

    According to the results reported on ClinicalTrials.gov, this trial (NCT04254549) looked at whether an intervention treatment had any effect on bloating symptoms compared to a placebo (a dummy treatment with no active ingredient). A total of five people took part — four in the intervention treatment group and one in the placebo group. The trial measured changes in bloating and related symptoms using a combination of four questionnaires, covering quality of life, stomach symptoms, anxiety and depression, and digestive discomfort, with participants answering up to 45 questions in total. The reported data shows that all five participants completed the study — none dropped out. For the primary outcome measure (improvement in bloating based on overall questionnaire scoring), the results were recorded by number of participants: four participants were in the intervention treatment group and one was in the placebo group. However, the data submitted to ClinicalTrials.gov does not include the actual questionnaire scores or score changes for either group — only the participant counts were reported for this outcome measure. This means it is not possible to describe what change, if any, was observed in bloating symptoms from the numbers provided. It is also worth noting that with only five participants across both groups, this was a very small study. No secondary outcome measure data was reported in the submitted results. 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 ↗

  • NCT04869670 · results posted 22 May 2026

    According to the results reported on ClinicalTrials.gov, this trial (NCT04869670) was designed to compare a procedure called G-POEM (a type of endoscopic procedure for a stomach-emptying condition called gastroparesis) against a sham procedure — meaning a fake or placebo procedure. The trial aimed to measure changes in stomach-related symptoms and quality of life in participants. However, the reported data shows that only two people were enrolled in the G-POEM group and no one was enrolled in the sham procedure group. Of the two people who started in the G-POEM group, only one completed the study. The reported data shows two sets of measurements, though it is important to note that with such a very small number of participants, these figures reflect only one or two individuals rather than a broad group. For the primary outcome — a symptom score called the GCSI-DD, which rates stomach symptoms such as nausea, bloating, and pain on a scale of 0 (no symptoms) to 4 (very severe) — the G-POEM group had a reported score change of 2.5, compared to 0.3. For the secondary outcome — a quality-of-life score called the PAGI-QoL, rated on a scale of 0 (lowest quality of life) to 5 (highest) — the G-POEM group had a reported score change of 3.73, compared to 0.83. Because no participants were enrolled in the sham group, it is unclear how the comparison figures of 0.3 and 0.83 were calculated; the data does not explain this, and no further detail was reported. Given that the trial enrolled only two participants total and appeared to stop far short of its intended size, the reported numbers represent an extremely limited dataset. The data was reported as submitted, but what these figures mean in any broader sense was not addressed in the structured results provided to 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.

    View reported results on ClinicalTrials.gov ↗

  • NCT05004012 · results posted 29 April 2026

    According to the results reported on ClinicalTrials.gov, this trial enrolled participants across four groups: a Control group (6 people), a Gastroparesis group (8 people), a Functional Dyspepsia group (6 people), and a G-POEM group (0 people enrolled). In total, 20 people started the study. Of these, 17 completed it — all 6 in the Control group, 5 of 8 in the Gastroparesis group, and all 6 in the Functional Dyspepsia group. The trial was measuring physical characteristics of the stomach, including how often the stomach contracts, the size of the pylorus (the opening between the stomach and the small intestine), and how severe participants' digestive symptoms were. The reported data shows that, at the start of the study, the stomach contraction rate was 20 contractions per minute in the Control group, 24.6 in the Gastroparesis group, and 23.7 in the Functional Dyspepsia group. The pylorus diameter was reported as 10.20 millimetres in the Control group, 13.40 millimetres in the Gastroparesis group, and 9.38 millimetres in the Functional Dyspepsia group. Symptom severity (measured on a scale of 0 to 20, where higher means more severe) was reported as 10.8 for the Gastroparesis group and 3.5 for the Functional Dyspepsia group — no score was reported for the Control group. The reported data also shows that zero participants in any group experienced a procedure-related adverse event (an unwanted event linked to the study procedure). Results for the additional measure tracking the movement of markers through different parts of the stomach 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.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04026997 · results posted 25 March 2026

    According to the results reported on ClinicalTrials.gov, this trial (NCT04026997) enrolled 72 people in total across four groups. Thirty people received the investigational treatment at 10 mg twice daily (Cohort 1), 15 received it at 20 mg once daily (Cohort 2), 9 received it at 5 mg twice daily (Cohort 3), and 18 received a placebo (an inactive treatment used for comparison). Almost all participants finished the study — only one person in Cohort 1 did not complete it. The trial was measuring how the treatment affected the speed at which the stomach empties food, using a breath test, and also how participants rated their gastroparesis symptoms (such as nausea, bloating, and feeling full quickly) using a daily diary questionnaire scored from 0 to 4. The reported data shows that for the primary measure — the time it took for half of a test meal to leave the stomach — starting (baseline) figures ranged from roughly 119 to 163 minutes across groups. After treatment, the reported changes in stomach-emptying time were: Cohort 1 (10 mg twice daily) saw a reduction of about 10.6 minutes compared to its placebo group's reduction of about 8 minutes; Cohort 2 (20 mg once daily) saw a reduction of about 12.4 minutes; figures for Cohort 3 and some placebo comparisons were not fully reported in the data provided. In percentage terms, Cohort 1 showed approximately a 4.2% reduction and Cohort 2 showed approximately a 9.3% reduction, while the corresponding placebo groups showed a 1.4% reduction and a 3.2% increase respectively. For the secondary symptom diary scores, the reported data shows all groups — including placebo — had lower (improved) symptom scores at the end of the study compared to the start, with percent reductions ranging from roughly 27% to 65% across all groups and time points. 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 ↗

  • NCT06533527 · results posted 5 December 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT06533527) involved 60 people in total — 28 in one group and 32 in another. All 60 participants completed the study with no dropouts. The trial was looking at what happens when people take a GLP-1 medication (a type of medication commonly used for diabetes or weight management) before having an endoscopy — a procedure where a camera is passed into the stomach. Specifically, the study compared two groups: those who **continued taking their medication as normal** before the procedure, versus those who **held (paused) their dose** before the procedure. The main things being measured were whether there was leftover food or liquid in the stomach that could get in the way of the procedure, whether a breathing tube was needed because of this, and whether anyone accidentally inhaled stomach contents during the procedure. The reported data shows that when looking at leftover stomach contents that could interfere with the endoscopy, 7 out of 28 people in the "continue medication" group had this recorded, compared to 1 out of 32 people in the "hold dose" group. For the other two primary outcomes — needing a breathing tube due to stomach contents, and any incidents of stomach contents being inhaled — the reported numbers were zero in both groups, meaning neither of these events was recorded for any participant in either 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 ↗

  • NCT04303195 · results posted 28 August 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT04303195) enrolled 161 people in total, split across four groups: 40 people received a 5 mg dose of NG101, 41 received a 10 mg dose, 40 received a 20 mg dose, and 40 received a placebo (a dummy treatment with no active ingredient). The trial was measuring changes in stomach-related symptoms — such as nausea, feeling full too quickly, feeling overly full after eating, abdominal pain, and vomiting — in people with a stomach condition called gastroparesis (where the stomach empties more slowly than normal). Participants rated their symptoms daily on a scale of 0 (no symptoms) to 10 (worst possible), and scores were tracked over a 12-week treatment period. By the end of the study, 35, 35, 31, and 33 people had completed the trial in each group respectively. The reported data shows that all four groups — including the placebo group — had lower (improved) symptom scores compared to where they started. For the main measure, nausea severity, the reported average reductions from the starting score were: −3.55 points for the 5 mg group, −3.65 points for the 10 mg group, −3.43 points for the 20 mg group, and −2.83 points for the placebo group. For the combined three-symptom score (nausea, early fullness, and post-meal fullness averaged together), the reported reductions were −3.16, −3.28, −2.92, and −2.85 points respectively. For vomiting episodes, all groups reported reductions of less than one episode per day on average, ranging from −0.31 (placebo) to −0.50 (10 mg group). The reported data shows similar patterns across the other secondary measures — early satiety, post-meal fullness, and abdominal pain — with all groups recording reductions in scores over the treatment period. The numbers reported for each of these outcomes were broadly comparable across the NG101 dose groups and the placebo group. No data was reported for any outcomes beyond those listed above. 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 ↗

  • NCT03941288 · results posted 13 February 2024

    According to the results reported on ClinicalTrials.gov, this trial enrolled 92 people across four groups: 25 received cannabidiol (CBD) and 23 received a placebo among participants with functional dyspepsia (a condition causing ongoing stomach discomfort without a clear physical cause), and 21 received CBD and 23 received a placebo among participants with gastroparesis (a condition where the stomach empties food more slowly than normal). Most participants finished the study — 22, 21, 20, and 22 people respectively completed it across the four groups. The trial measured how the stomach processes food, including how quickly it empties, how much it expands after eating, and how much food people could comfortably drink before feeling completely full. The reported data shows the following numbers for stomach-emptying speed (measured as the time for half the food to leave the stomach): in the functional dyspepsia groups, the CBD group recorded 128.7 minutes and the placebo group 125.8 minutes; in the gastroparesis groups, the CBD group recorded 246.4 minutes and the placebo group 198.4 minutes. For how long food stayed in the stomach before it started moving into the small bowel, the functional dyspepsia CBD group recorded 46.0 minutes versus 52.1 minutes for placebo, and the gastroparesis CBD group recorded 83.0 minutes versus 60.8 minutes for placebo. For stomach volume while fasting, the reported figures ranged from 179.0 mL to 235.6 mL across groups, and for how much the stomach expanded after a drink, figures ranged from 410.2 mL to 440.6 mL. The reported data also shows results for how much participants could drink before feeling full: in the functional dyspepsia CBD group, the volume at which people first reported a "typical meal" level of fullness was 373.3 mL, compared with 622.1 mL in the placebo group; in the gastroparesis groups, it was 682.6 mL (CBD) versus 638.2 mL (placebo). For the point of maximum or unbearable fullness, the functional dyspepsia CBD group reached that point at 808.8 mL compared with 871.0 mL for placebo, while the gastroparesis CBD group reached it at 1,061.6 mL compared with 812.7 mL for placebo. 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 ↗

  • NCT05270460 · results posted 21 July 2023

    According to the results reported on ClinicalTrials.gov, this trial enrolled 25 people in total across three groups: 9 received a low dose of an investigational treatment called PCS12852 (0.1 mg), 8 received a higher dose (0.5 mg), and 8 received a placebo (a dummy treatment with no active ingredient). All 9 in the low-dose group and all 8 in the placebo group finished the trial, while 2 of the 8 in the higher-dose group did not complete it. The trial was measuring how the stomach emptied food (called "gastric emptying"), how much of the treatment was absorbed into the blood, and how participants rated their stomach-related symptoms over 28 days. The reported data shows that for the main stomach-emptying measure (called AUC, which captures the overall pattern of how quickly the stomach emptied), the numbers at day 28 were 267 units for the low-dose group, 283 units for the higher-dose group, and 222 units for the placebo group. For a second emptying measure — the time it took for half the stomach contents to empty (called t50) — the reported changes from the start of the trial were minus 4.89 minutes for the low-dose group, minus 26.64 minutes for the higher-dose group, and minus 11.15 minutes for the placebo group (negative numbers meaning emptying appeared faster than at the start). For blood levels of PCS12852, the peak concentration recorded was 0.12 ng/mL in the low-dose group and 0.60 ng/mL in the higher-dose group. The reported data shows that for symptom scores — where participants rated stomach symptoms like nausea, fullness, and pain on a 0-to-4 scale (with higher scores meaning worse symptoms) — changes from baseline ranged from small reductions across all three groups, including the placebo group, across the two secondary measures reported. No variability or precision data (such as standard deviations) were included in the submitted results, so the spread of individual responses cannot be described. 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 ↗

  • NCT03587142 · results posted 15 June 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT03587142) enrolled 96 people in total — 47 received buspirone and 49 received a placebo (a dummy pill with no active ingredient). By the end of the study, 39 people in each group had completed the trial. The trial was measuring changes in stomach-related symptoms — specifically feelings of fullness after eating, not being able to finish a normal meal, excessive fullness, loss of appetite, and an overall symptom score — over a 4-week period. Participants rated the severity of these symptoms on a scale from 0 (no symptoms) to 5 (very severe), and the trial tracked how much those scores changed from the start to the end of the 4 weeks. The reported data shows that both groups had lower symptom scores at 4 weeks compared to when they started, meaning scores moved in a negative direction (which indicates improvement on this scale). For the main measure — a combined score covering postprandial fullness and early satiety — the buspirone group's score changed by −1.16 points on average, while the placebo group's score changed by −1.03 points. For the individual symptoms, the reported changes were similarly close between the two groups: stomach fullness (buspirone −1.16, placebo −1.07), excessive fullness (buspirone −1.14, placebo −0.99), inability to finish a normal meal (buspirone −1.27, placebo −1.12), and loss of appetite (buspirone −1.09, placebo −0.96). For the broader overall symptom score covering nausea, vomiting, and bloating as well, the buspirone group reported a change of −1.06 compared to −0.86 in 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.

    View reported results on ClinicalTrials.gov ↗

  • NCT03712124 · results posted 5 January 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT03712124) enrolled 21 participants in total — 10 in the CNSA-001 group and 11 in the placebo group. The trial was studying a condition called gastroparesis (a disorder where the stomach empties more slowly than normal), and it was measuring things like how much liquid food participants could comfortably drink before feeling completely full, how quickly their stomachs emptied food, and how severe their stomach symptoms were over a 28-day period. The reported data shows that for the main measurement — the maximum amount of a nutritional drink (Ensure™) participants could consume before feeling unbearably full — the CNSA-001 group started at a baseline of around 293.5 mL and the placebo group at around 345.6 mL. By Day 28, the reported change from that starting point was an increase of about 75.3 mL in the CNSA-001 group, compared to a decrease of about 30.9 mL in the placebo group. For stomach symptom scores (measured using standardised questionnaires), both groups reported reductions in symptom severity scores at Day 14 and Day 28, with the reported numbers being broadly similar between the two groups. For the stomach-emptying breath test, the reported figures across measurement time points were also similar between both groups. Regarding reported adverse events (unexpected medical occurrences during the trial), 4 out of 10 participants in the CNSA-001 group and 2 out of 11 in the placebo group reported at least one adverse event — however, no further breakdown of these events was included in the structured 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 ↗

  • NCT03420781 · results posted 22 December 2021

    According to the results reported on ClinicalTrials.gov, this trial looked at a medication called relamorelin (given as a 10 microgram injection) compared to a placebo (an inactive injection) in people with diabetic gastroparesis — a condition where the stomach empties more slowly than normal due to diabetes. A total of 467 participants started the main 40-week treatment phase (236 on placebo, 231 on relamorelin), and a smaller group of 193 participants then went on to a further 6-week follow-up period. The trial tracked participants' daily symptom scores covering nausea, abdominal pain, bloating, and the feeling of fullness after eating, as well as vomiting episodes. The reported data shows that at the start of the trial, both groups had very similar average total symptom scores of around 24.8–24.9 out of a possible 40 (where higher scores mean worse symptoms). After 12 weeks, both groups showed a decrease in their scores — the placebo group's score fell by about 11.9 points on average, and the relamorelin group's score fell by about 11.2 points. For the vomiting measure, 29.4% of the placebo group and 21.4% of the relamorelin group met the criterion of having no vomiting episodes across the last six of those first 12 weeks. The reported data also shows that for the secondary measures — including the proportion of participants who had meaningful improvements in nausea, abdominal pain, bloating, and post-meal fullness — the figures were broadly similar between the two groups, ranging from roughly 36% to 46% depending on the symptom and 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.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗

  • NCT03786380 · results posted 15 December 2021

    According to the results reported on ClinicalTrials.gov, this trial involved 202 participants in total, spread across five different treatment groups. The groups varied in whether participants received the study drug relamorelin, a placebo (an inactive substance), or a combination of both across different stages of the trial. The trial was primarily measuring how many participants experienced notable medical events, unusual laboratory test results, changes in vital signs (such as blood pressure and heart rate), or unusual heart-tracing (ECG) results while on the study drug. The reported data shows that when it came to unwanted medical events that appeared or worsened during treatment — known as "treatment-emergent adverse events" — the numbers ranged across the five groups: 16, 11, 27, 27, and 16 participants respectively reported at least one such event. For laboratory test results that were flagged as potentially clinically significant (meaning they stood out enough for the investigator to take note), the reported data shows very small numbers — mostly zero participants per group, with a handful of isolated individual results noted in certain groups. For vital signs, the reported data shows that no participants in any group were recorded as having clinically meaningful trends. Similarly, for heart-tracing (ECG) results, no participants in any group were recorded as having clinically meaningful trends. It is worth noting that the data shows zero participants recorded as having "completed" the trial in the conventional sense, which may reflect how the study's completion was defined and recorded rather than participants dropping out. These summary numbers are what was submitted to the registry and do not include further context about the nature of individual events. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗

  • NCT03383146 · results posted 23 November 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT03383146) enrolled 450 people in total — 148 in the placebo group and 302 in the relamorelin 10 μg group — though not all of them completed the study. The trial was looking at a condition called diabetic gastroparesis, where the stomach empties too slowly in people with diabetes. Participants rated four symptoms daily — nausea, stomach pain, feeling overly full after eating, and bloating — on a scale of 0 to 40, where higher numbers mean worse symptoms. The trial measured how much those scores changed over 12 weeks and 52 weeks. The reported data shows that at the start of the study, both groups had similar average symptom scores (around 20 out of 40). After 12 weeks, the placebo group's score had dropped by an average of 7.1 points, while the relamorelin group's score had dropped by an average of 6.5 points. After 52 weeks, the placebo group's score had dropped by an average of 10.7 points, while the relamorelin group's score had dropped by an average of 8.6 points. In both cases, a drop in score means symptoms were reported as less severe than at the start. The reported data also shows that 105 out of 145 placebo participants and 221 out of 299 relamorelin participants experienced at least one adverse event (an unwanted medical occurrence during the study period). No participants in either group were reported to have clinically meaningful changes in vital signs, and 2 participants in each group had clinically significant abnormal heart-trace (ECG) results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗

  • NCT04684992 · results posted 24 August 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT04684992) enrolled 36 participants, of whom 34 completed the study and 2 did not finish. The trial was looking at whether people could carry out a specific breath test — called the Gastric Emptying Breath Test (GEBT), which measures how quickly the stomach empties — entirely from home, guided by a health professional via telehealth (a video or phone call). The test involved drinking a special liquid containing a substance called 13C-Spirulina, collecting breath samples at set times, filling in a request form, and then posting the samples back to a laboratory. The reported data shows that across all the key steps measured — preparing and taking the test, filling out the required paperwork, collecting the breath samples correctly, and successfully sending the test kit and samples to and from home — the numbers recorded were consistently 33 or 34 out of the 34 participants who completed the trial. These figures were assessed in several different ways: by a telehealth professional watching the participant during the session, by checking whether the breath samples contained the right amount of air collected in the correct order, by laboratory staff checking the paperwork when samples arrived, and by a questionnaire completed by participants themselves. The reported data does not include information on any side effects or health outcomes beyond whether participants were able to complete each step of the process as instructed. No figures were reported for participants who were unable to complete individual steps beyond the small variations (33 versus 34) noted across certain measurements, and no further breakdown of those differences was provided 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 ↗

  • NCT03285308 · results posted 29 July 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT03285308) enrolled 336 people with diabetic gastroparesis — a condition where the stomach empties more slowly than normal in people with diabetes. Participants were randomly assigned to receive either a placebo (an inactive treatment) or a drug called relamorelin (10 micrograms), with 167 people starting in the placebo group and 169 in the relamorelin group. The trial ran for 12 weeks and measured changes in four stomach-related symptoms — nausea, abdominal pain, bloating, and feeling full after eating — as well as vomiting episodes. The reported data shows that for the main (primary) symptom score — which combined all four symptoms on a scale of 0 (no symptoms) to 40 (worst possible) — both groups started at similar levels (around 25 points). By week 12, the placebo group's score had dropped by an average of 10.0 points, while the relamorelin group's score had dropped by an average of 9.3 points. For the other primary measure — the proportion of participants who had no vomiting episodes across the final six weeks of the trial — 19.5% of the placebo group and 21.8% of the relamorelin group met this criterion. The reported data for the secondary outcomes shows broadly similar results between the two groups. For nausea improvement, 34.1% in the placebo group and 29.7% in the relamorelin group met the response threshold. For abdominal pain, the figures were 28.0% and 27.9% respectively. For bloating, 26.2% (placebo) and 27.9% (relamorelin) responded, and for feeling full after eating, 22.6% (placebo) and 25.5% (relamorelin) met the response criterion. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01989221 · results posted 26 May 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT01989221) enrolled 14 participants, and all 14 completed the study. The trial was a crossover design, meaning participants first received a placebo (an inactive treatment) and then received Sancuso — a skin patch containing a medicine called granisetron, sometimes referred to as GTS. The trial was measuring the severity of stomach-related symptoms in people with a condition called gastroparesis (where the stomach is slow to empty), using a daily symptom diary called the GCSI-DD. This diary asked participants to rate symptoms such as nausea, feeling full quickly, bloating after meals, and upper stomach pain on a scale from 0 (no symptom) to 4 (very severe). The reported data shows that for the main (primary) measure — an overall composite symptom score combining several stomach symptoms — scores were recorded at three points: a starting (baseline) score of 1.89, followed by scores of 1.57 and then 1.34 at the two measurement points during treatment. For the secondary measure focusing specifically on nausea and vomiting symptoms, the reported scores were 2.31 at baseline, then 1.69 and 1.30 at the two later time points. All scores were on the same 0–4 scale, where lower numbers indicate less severe symptoms. The reported data does not include a separate breakdown of scores during the placebo period compared to the Sancuso period. It is worth noting that because the same group of 14 people received both placebo and Sancuso at different times, and the results are reported together as one group, the data as submitted does not allow a direct side-by-side comparison of placebo versus Sancuso outcomes to be described 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.

    View reported results on ClinicalTrials.gov ↗

  • NCT03342157 · results posted 23 October 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT03342157) enrolled a very small number of participants — just two people in total, one assigned to a high-dose group and one to a low-dose group. Both participants completed the study without dropping out. The trial was measuring stomach-related symptoms using a tool called the Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD), which asks people to rate symptoms like nausea or fullness on a scale from 0 (no symptoms) to 5 (very severe). It also looked at how often participants used extra "breakthrough" medication to manage symptoms, and how often they had bowel movements. The reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of the three outcome measures — the primary symptom score, the breakthrough medication use, or the bowel movement frequency. In other words, while the trial was completed by both participants, the actual measurements and findings for all outcomes were not reported in the structured results data available on ClinicalTrials.gov. Because no outcome numbers were provided, it is not possible to describe what the trial found in terms of changes to symptoms or medication use. The data was simply not reported. Given the very small number of participants (two people), this trial was also far too small to draw any broader conclusions, and no such conclusions should be drawn from 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 ↗

  • NCT02025751 · results posted 7 July 2020

    According to the results reported on ClinicalTrials.gov, this trial involved 53 people in total — 26 received a metoclopramide nasal spray and 27 received a placebo (dummy) nasal spray. The trial was looking at symptoms of a stomach condition called gastroparesis, where the stomach is slow to empty. Participants rated their symptoms daily using a questionnaire called the Gastroparesis Symptom Assessment (GSA), which runs on a scale from 0 (no symptoms) to 4 (very severe symptoms). The main thing being measured was how much those symptom scores changed from the start of the trial to the end of four weeks of treatment. The reported data shows that both groups had lower symptom scores at week four compared to where they started. The group using the metoclopramide nasal spray had an average score decrease of 0.751 points, while the group using the placebo nasal spray had an average score decrease of 0.657 points — both measured on that 0–4 scale. No further breakdown of these numbers, such as how the groups compared to each other in a formal statistical test, was included in the data submitted to ClinicalTrials.gov. It is also worth noting that one person in the metoclopramide group and three people in the placebo group did not complete the trial, though the reasons 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.

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  • NCT02025725 · results posted 11 February 2020

    According to the results reported on ClinicalTrials.gov, this trial looked at a nasal spray version of a medicine called metoclopramide (at a dose of 10 mg) compared to a dummy (placebo) nasal spray, in people with a stomach condition called gastroparesis — where the stomach empties more slowly than normal. A total of 102 people were assigned to the metoclopramide nasal spray group and 103 to the placebo group. By the end of the study, 91 people in the active spray group and 99 in the placebo group had completed the trial. The main thing being measured was a symptom score called the Gastroparesis Symptom Assessment (GSA), which runs from 0 (no symptoms) to 4 (very severe symptoms). The reported data shows that, after four weeks, people in the metoclopramide nasal spray group had an average score reduction of 0.925 points from their starting score, while those in the placebo group had an average reduction of 0.896 points. A reduction means symptoms were reported as less severe than at the start, but both groups showed a similar degree of change. A separate, additional analysis (done after the main results were collected) looked only at participants who started with moderate to severe symptoms. The reported data shows that, by week four, this subgroup using the metoclopramide spray had an average score reduction of 1.218 points, compared to 0.857 points in the placebo subgroup. Reductions were also reported at weeks one, two, and three for this subgroup, with the active spray group consistently showing somewhat larger reductions at each time 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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  • NCT03268941 · results posted 23 July 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT03268941) studied an investigational medicine called TAK-906 Maleate, given at three different doses (5 mg, 25 mg, and 100 mg), compared to a placebo (inactive treatment) and, in a separate part of the trial, compared to an existing medicine called metoclopramide (10 mg). The trial was split into two parts. In Part 1, a total of 51 people took part across the placebo and three TAK-906 dose groups. In Part 2, a smaller group of participants (around 6 to 15 people per group) received TAK-906 25 mg either with food or fasted, or metoclopramide. The trial was primarily measuring participants' experiences of adverse events (unexpected medical occurrences after taking the study drug), as well as checking blood test results, vital signs such as heart rate and blood pressure, and heart tracing (ECG) readings. Secondary measures included changes in a hormone called prolactin in the blood, and a breath test used to measure how quickly food moves out of the stomach. The reported data shows that in Part 1, 4 participants in each of the placebo, 5 mg, and 100 mg groups, and 3 participants in the 25 mg group, experienced at least one adverse event after taking the study drug. One serious adverse event was reported each in the placebo and 100 mg groups; none were reported in the other groups. In Part 2, one adverse event was reported in the fed-condition TAK-906 group and one in the metoclopramide group; none were reported in the fasted TAK-906 group. For laboratory blood test results, only Part 1 data was reported: one participant in the 5 mg group had a markedly abnormal result in one category, and small numbers of single abnormal readings were noted across other groups. Regarding ECG readings, small numbers of participants — including one each in the placebo and 5 mg groups in Part 1 — had values outside the defined normal range. For the secondary outcomes, the reported data shows that prolactin levels (measured as a ratio compared to baseline) were higher in all TAK-906 groups (12.77 for 5 mg, 19.92 for 25 mg, and 20.07 for 100 mg) compared to the placebo group (1.54). For the stomach-emptying breath test on Day 7, the reported half-emptying times (the time for half the food to leave the stomach) were 118.74 minutes for placebo, 130.18 minutes for 5 mg, 121.26 minutes for 25 mg, and 122.50 minutes for 100 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.

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  • NCT00595621 · results posted 31 May 2019

    According to the results reported on ClinicalTrials.gov, this trial looked at a device called MGP-1, which was tested in people with a stomach condition called gastroparesis (where the stomach empties food more slowly than normal). The trial started with 22 participants in an open run-in phase, where everyone used the device switched on. Of those, 19 completed that phase, and 19 were then randomly assigned to one of two groups — 10 with the device turned "ON" and 9 with it turned "OFF" — to compare what happened under each condition over up to three months. The reported data shows that the main thing being measured was how well the device could influence the stomach's natural electrical rhythm, specifically the percentage of normal slow waves (electrical signals at 2–4 cycles per minute) detected while the device was on versus off. The reported figures were 72% (device ON) compared to 70% (device OFF) at one point, and 84% versus 78% at another. For the secondary measurements, the percent of a solid meal still sitting in the stomach at 4 hours was reported as 46% (ON) and 36% (OFF) at one time point, and 33% (ON) versus 42% (OFF) at another. Symptom severity scores — rated on a scale of 0 (no symptoms) to 28 (all symptoms extremely severe) — were reported as 13 (ON) versus 14 (OFF) at one point, and 6 (ON) versus 16 (OFF) at another. Quality-of-life scores (percentage change from the start of the study) were reported as 60% (ON) versus 30% (OFF) for physical wellbeing, and 55% (ON) versus 40% (OFF) for mental wellbeing. A blood sugar marker (HbA1c) was reported as 8.1% (ON) and 8.2% (OFF), and average days spent in hospital were reported as 1.5 days (ON) versus 2.1 days (OFF). It is worth noting that the data as submitted does not clearly label which measurements belong to which time point, so some figures may represent different stages of 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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  • NCT01030341 · results posted 4 September 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 45 people in total, all of whom had diabetes with a condition called gastroparesis (a stomach-emptying problem). Forty-two participants completed the study, and three did not finish. The trial was measuring whether using a continuous glucose monitor (a small device that tracks blood sugar levels throughout the day) combined with an insulin pump changed the rate of low blood sugar episodes, stomach symptoms, and quality of life over 24 weeks, compared to a screening period beforehand. The reported data shows that low blood sugar episodes — defined as blood sugar dropping below 70 mg/dL (a mild-to-moderate episode) or below 50 mg/dL (a severe episode) — were measured as an event rate per person per week. The numbers reported were 1.9 and 2.2 events per person per week (these appear to reflect the two different time points or thresholds measured, though the data as submitted does not fully distinguish between them). For stomach symptoms, the trial used a questionnaire called the GCSI, scored from 0 to 5 where higher scores mean worse symptoms. The reported changes in total and average GCSI scores were −7.2 and −7.1 (noting these appear to be total score point changes) and −0.6 and −0.8 (mean score changes). For quality of life, measured using a separate questionnaire called the PAGI-QOL (scored 0–5, where higher means better quality of life), the reported changes were +0.7 and +0.7 at the time points assessed. It is worth noting that because all 45 participants were in a single group with no comparison group reported, the data as submitted to ClinicalTrials.gov does not include a separate control or comparison group to contrast these numbers against. 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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  • NCT02130622 · results posted 17 May 2018

    According to the results reported on ClinicalTrials.gov, this trial was comparing promethazine (a medication sometimes used for nausea) against a sugar pill (placebo) in people with a stomach condition called gastroparesis — where the stomach empties more slowly than normal. The trial set out to measure changes in self-reported symptoms using a standard symptom scoring tool, as well as tracking any unwanted effects, use of a backup medication, and the impact on participants' ability to work and carry out daily activities. The reported data shows that only three people took part in the trial in total — two in the promethazine group and one in the sugar pill group — and all three completed the study. This is an extremely small number of participants. Despite the trial being completed, the reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of the outcome measures — not for the symptom score, not for adverse events, not for use of the backup medication, and not for work and activity impact. Because no measurement data was reported, it is not possible to describe what the numbers showed for any of these 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.

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  • NCT01934192 · results posted 9 November 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 92 people in total across four groups. Most participants (40 and 44 people respectively) were already tolerating tube feeding at the start and were given either a placebo followed by camicinal, or camicinal followed by metoclopramide (another medicine). A smaller group of 8 people who were not tolerating tube feeding were given either camicinal or metoclopramide. The trial was measuring how much of a person's prescribed tube-feeding nutrition they actually received, and was comparing a drug called camicinal (50 mg) against a placebo (a dummy treatment with no active ingredient). The reported data shows that, for the main measurement — the average percentage of the prescribed tube-feed volume delivered before any feeding intolerance developed — participants in the camicinal group received an average of 76.6% of their prescribed volume, compared with 67.7% in the placebo group (in the full group of enrolled participants). In a separate analysis limited to participants who followed the study protocol most closely, both groups received around 76.6% and 74.4% respectively. For the secondary measurements, the camicinal group was reported to have received an average of 76.7% of their prescribed calories and 76.3% of their prescribed protein, compared with 67.8% and 69.8% respectively in the placebo group. The reported data also shows that the estimated time to reaching 80% of prescribed calories was 2 days in the camicinal group and 1 day in the placebo group. Regarding adverse events (unexpected medical occurrences during the trial), the numbers of participants who experienced these were reported across each group, but no safety conclusions are drawn 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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  • NCT02210000 · results posted 1 November 2017

    According to the results reported on ClinicalTrials.gov, this trial involved 114 people in total — 57 who received a medicine called camicinal (25 mg) and 57 who received a placebo (a dummy treatment with no active ingredient). The trial was studying people with a stomach condition called gastroparesis, where the stomach empties more slowly than normal. The main thing the trial was measuring was how many people reported meaningful improvement in feelings of fullness and early satiety (feeling full very quickly after starting to eat) after 12 weeks, using a patient-reported symptom diary called the GCSI-DD. By the end of the study, 38 people in the camicinal group and 36 in the placebo group had completed the trial. The reported data shows that for the main outcome — the proportion of people who reported a meaningful improvement in fullness and early satiety symptoms — 26.32% of those taking camicinal were recorded as responders, compared with 42.11% of those taking the placebo. For the secondary outcomes, which looked at changes in individual symptom scores across the diary (including nausea, vomiting, bloating, stomach fullness, and overall severity), the reported data shows that both groups had reductions in their symptom scores from the start of the trial to week 12, with the placebo group generally showing slightly larger reductions in most categories. The secondary measures also recorded information about blood pressure changes, heart rate, heart tracing (ECG) readings, and blood test results over the study period; the numbers of participants with readings outside normal ranges were broadly similar between the two groups, though the reported data does not allow a straightforward comparison without further clinical context. 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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  • NCT01262898 · results posted 13 October 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 79 people across four groups: 21 received a placebo (a dummy treatment with no active ingredient), 18 received a 10 mg dose of GSK962040, 18 received a 50 mg dose, and 22 received a 125 mg dose. The trial was measuring how quickly the stomach emptied its contents in people who took the study drug compared to those who took the placebo. Stomach emptying was tracked using a breath test that detected a harmless, non-radioactive marker added to a test meal. The main outcome being measured was the time it took for the stomach to empty half its contents (called the "gastric half emptying time"), recorded in minutes. The reported data shows that at the start of the study (Day 1, before dosing), the average time for the stomach to empty halfway was around 131 minutes for the placebo group, 107 minutes for the 10 mg group, 118 minutes for the 50 mg group, and 131 minutes for the 125 mg group. By Day 28, those figures were reported as approximately 124 minutes (placebo), 107 minutes (10 mg), 105 minutes (50 mg), and 99 minutes (125 mg). The reported data also shows that small changes in blood pressure, heart rate, and heart electrical activity (measured by ECG) were recorded across all groups, with no single group showing a notably large or consistent change. In terms of unwanted medical events during the trial ("adverse events"), 13 people in the placebo group, 14 in the 10 mg group, 13 in the 50 mg group, and 18 in the 125 mg group experienced at least one such event. Serious adverse events were reported in 1 person in the placebo group, 0 in the 10 mg group, 1 in the 50 mg group, and 0 in the 125 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.

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  • NCT00492622 · results posted 28 July 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 12 participants, and all 12 completed the study with none dropping out. The trial was comparing two different formulations of omeprazole (a medication commonly used for stomach acid) — an immediate-release version and a delayed-release version. The study was measuring how the drug moved through participants' bodies, specifically how quickly it reached its highest level in the blood, how high that peak level was, and the total amount of the drug that was absorbed over time. The reported data shows the following numbers for the three main measurements. For the time it took the drug to reach its highest level in the blood, the immediate-release version reached its peak at around 32 minutes on average, while the delayed-release version took around 97 minutes. For the peak level of the drug detected in the blood, the immediate-release version recorded 1,979 ng/mL (nanograms per millilitre, a measure of concentration) compared to 1,625 ng/mL for the delayed-release version. For the total amount of drug absorbed over time (measured using a calculation called "area under the curve," which adds up drug levels across multiple time points), the immediate-release version recorded 3,842 mg\*h/mL and the delayed-release version recorded 3,745 mg\*h/mL. 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 ↗

  • NCT01892267 · results posted 17 May 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 19 people who needed a type of feeding tube called a PEG-J tube — a tube inserted through the stomach wall to deliver nutrition directly into the small intestine. Participants were split into two groups: 9 people received a "self-propelled" version of this tube, and 10 received a standard version. All 19 participants completed the study. The trial was primarily looking at how often the tube moved out of position (called "migration") within 4 weeks of being placed, and also tracked a number of secondary measures such as how often the tube was successfully placed, how long the procedure took, and whether repeat procedures were needed. The reported data shows that when tubes were checked by X-ray at 4 weeks, 3 out of 9 participants in the self-propelled group and 3 out of 10 in the standard group had experienced tube migration. Regarding technical success — meaning the tube was placed in the right spot as confirmed during the procedure — 8 out of 9 placements were reported as successful in the self-propelled group, compared to 10 out of 10 in the standard group. For those whose tubes had migrated, 3 participants in each group went on to need a repeat procedure to reposition the tube. The reported average time to complete the tube placement procedure was 17.2 minutes for the self-propelled group and 28.7 minutes for the standard group. Two other measures — how long the tube remained usable before needing attention, and the time until a repeat procedure was needed — 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.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01602549 · results posted 6 February 2017

    According to the results reported on ClinicalTrials.gov, this trial (NCT01602549) enrolled 57 people in total — 19 received a placebo (a dummy treatment with no active ingredient) and 38 received the investigational drug GSK962040. Nearly all participants finished the study: 18 in the placebo group and 37 in the GSK962040 group completed it, with just one person leaving each group early. The trial was measuring how a drug called levodopa (L-DOPA, a common Parkinson's disease medication) was absorbed into the bloodstream when GSK962040 was also given — specifically looking at the amount of levodopa that entered the blood over time and how high the blood levels peaked. The reported data shows that at the starting point (baseline), before any treatment differences could take effect, the levodopa absorption figures were very similar between the two groups. The measure of total levodopa exposure over four hours (called AUC, or "area under the curve" — essentially a way of adding up drug levels in the blood over time) was 24.13 units for the placebo group and 24.81 units for the GSK962040 group at baseline. After one day of treatment (Day 1), the reported figures were 26.6 for placebo and 25.7 for GSK962040, and after eight days (Day 8) they were 27.1 for placebo and 24.1 for GSK962040. The peak levodopa blood level (Cmax) at baseline was 12.77 for the placebo group and 12.89 for the GSK962040 group; on Day 1 these were 13.4 versus 11.6, and on Day 8 they were 11.6 versus 11.8. The time it took levodopa to reach its peak in the blood (Tmax) was also recorded across baseline, Day 1, and Day 8, with figures ranging between approximately 1.5 and 2 hours across both groups. One planned measurement — the "half-life" of levodopa (how long it takes for blood levels to fall by half) — was not able to be calculated because there was not enough data from participants' blood profiles to work it out. 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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  • NCT01711918 · results posted 19 December 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 9 participants, all of whom received domperidone. Seven participants completed the trial, while 2 did not finish. The trial was measuring whether participants reported that their stomach-related symptoms improved after taking the medication. Symptoms looked at included overall discomfort, nausea, vomiting, abdominal bloating or distension, and feeling full too quickly after eating. Improvement was judged using a 6-point rating scale (called a Likert scale), where participants compared how they felt at the end of the trial to how they felt at the start — those who said they felt "somewhat better" or "markedly better" were counted as having responded. The reported data shows that for the primary measure — overall symptom improvement — 2 out of the participants were counted as responders (meaning they rated their overall symptoms as somewhat or markedly better). For the secondary measures, the reported numbers were similarly small: 2 participants reported feeling somewhat or markedly better for nausea, 2 for vomiting, and 2 for abdominal bloating or distension. For the symptom of feeling prematurely full after meals, the reported data shows that 1 participant met the threshold for improvement. The total number of participants assessed for each of these outcomes was not separately specified 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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  • NCT01206582 · results posted 4 February 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people in total — 11 in a group receiving a substance called hemin and 9 in a group receiving albumin (a comparison substance). By the end of the study, 9 people in the hemin group and 7 in the albumin group completed it, with 2 from each group not finishing. The trial was measuring several things related to a protein called heme-oxygenase 1 (HO-1) — essentially looking at its levels and activity in the blood — as well as how quickly the stomach empties food, digestive symptoms, nerve-related symptoms, and a kidney marker called creatinine. The reported data shows that, for HO-1 protein levels in the blood (measured in ng/mL, a very small unit of concentration), the hemin group's readings across four time points were 1.6, 10.6, 7.0, and 2.6, while the albumin group's readings were 1.5, 1.5, 1.2, and 1.0. For HO-1 activity in white blood cells, the hemin group's readings across the same time points were 38.5, 373.9, 126.2, and 30.1 (in standard activity units), compared with 42.1, 48.1, 36.1, and 60.1 in the albumin group. For stomach emptying time, both groups recorded similar figures across all time points, ranging roughly between 153 and 162 minutes. On the digestive symptom scale (where higher numbers mean more severe symptoms, on a 0–5 scale), the hemin group's scores moved from 3.1 down to 1.4 across time points, while the albumin group moved from 3.3 to 1.9. Nerve-related symptom scores and creatinine levels were also reported, with both groups showing broadly similar ranges across time points; the data for those measures was not reported with specific labels for each time point beyond the raw numbers 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.

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  • NCT00765895 · results posted 16 April 2015

    According to the results reported on ClinicalTrials.gov, this trial (NCT00765895) looked at nortriptyline (a type of older antidepressant sometimes used for other conditions) compared to a placebo (a dummy treatment with no active ingredient) in people with gastroparesis — a condition where the stomach empties more slowly than normal. A total of 130 people took part, with 65 in the nortriptyline group and 65 in the placebo group. All 130 participants completed the study. The trial measured whether participants experienced a meaningful reduction in their stomach symptoms over a 15-week treatment period. The reported data shows that the main thing being measured was whether a participant's score on the Gastroparesis Cardinal Symptom Index (GCSI) — a questionnaire that adds up nine stomach-related symptoms into a total score ranging from 0 to 45, where higher numbers mean worse symptoms — dropped by at least half on two visits in a row during the treatment period. According to the results reported on ClinicalTrials.gov, 15 out of 65 people in the nortriptyline group met this target, compared to 14 out of 65 people in the placebo group. The reported data shows very similar numbers between the two groups for this primary measure. No additional outcome measures were included in the submitted results data, so further details beyond this main measure 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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  • NCT01323582 · results posted 5 December 2014

    According to the results reported on ClinicalTrials.gov, this trial involved 26 people in total (12 in one group and 14 in the other) who had a condition called gastroparesis — a stomach condition where the stomach empties food more slowly than normal. The trial compared two antibiotics, erythromycin and azithromycin, to see whether either changed how quickly the stomach emptied food and how severe participants' symptoms were. It used a "crossover" design, meaning each person tried both medicines in sequence, with a break in between. By the end of the trial, 20 participants had completed both treatment periods. The reported data shows that the main thing being measured was the time it took for half of a test meal to leave the stomach (recorded in minutes using a breath test), as well as a symptom score called the Gastroparesis Cardinal Symptom Index (GCSI), where higher numbers mean worse symptoms. For the stomach-emptying time, the reported figures for the two groups were −1.6 minutes and −5.2 minutes (negative numbers meaning the time decreased compared with the other treatment). For the symptom score, the reported differences were −1.6 and −2.9 units across the two groups. A secondary measure looked at each medicine on its own: when pooled across both groups, erythromycin was associated with a reported change of −11.8 minutes in stomach-emptying time, and azithromycin with −15.0 minutes. Two other secondary measures — a quality-of-life score (NDI) and the time before emptying first began (TLAG) — were also reported, with small numerical differences between groups, though what these differences mean clinically was not explained 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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  • NCT01248221 · results posted 18 March 2013

    According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people in total — 15 healthy volunteers and 15 people with dyspepsia (a condition involving ongoing stomach discomfort or indigestion). All 30 participants completed the study. The trial was comparing two different ways of measuring how quickly food leaves the stomach: a standard nuclear imaging scan (called scintigraphy) and a newer breath test using a substance called 13C spirulina. The key measurement both methods looked at was the "gastric emptying half time" — that is, how many minutes it takes for half of a solid meal to move out of the stomach. The reported data shows that, using the imaging scan, the stomach half-emptying time was around 66 minutes for the healthy group and around 82 minutes for the dyspepsia group. Using the breath test, the figures were very similar — approximately 67 minutes for the healthy group and around 83 minutes for the dyspepsia group. The reported data also shows how much of the meal had left the stomach at three specific time points (60, 120, and 240 minutes). For example, at the 60-minute mark, the imaging scan recorded that roughly 47% of the meal had emptied in the healthy group compared with about 32% in the dyspepsia group. By the four-hour mark, both methods recorded that nearly all of the meal had emptied in both groups, with the healthy group slightly ahead of the dyspepsia group at each time 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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  • NCT00432835 · results posted 3 December 2012

    According to the results reported on ClinicalTrials.gov, this trial involved 58 people in total — 28 in one group and 30 in the other — all of whom had a condition called gastroparesis, where the stomach empties food more slowly than normal. The trial used a device that delivers mild electrical pulses to the stomach (called gastric stimulation), and it was designed in two phases: one group had the device switched on for the first four days and off for the next four, while the other group did the opposite. By the end, 22 and 23 participants respectively completed both phases. The trial was measuring three things: self-reported vomiting symptoms, self-reported nausea symptoms, and how quickly food moved through the stomach. The reported data shows that vomiting and nausea were rated by participants on a scale of 0 (none) to 4 (most severe). For vomiting, one group started with an average score of 1.82 and the other at 2.68 at the beginning of their respective phases. For nausea, starting scores were 3.27 and 3.33 — both near the higher end of the scale. The reported data shows scores generally appeared lower at later measurement points within each group, though the pattern differed between the two groups depending on when the device was activated. For stomach emptying, a scan measured how much of a test meal remained in the stomach at one, two, and four hours; the reported percentages varied across time points and between groups, with the four-hour figures dropping as low as 16.43% in one group and 24.11% in the other by the final measurement. It is worth noting that the data as submitted does not include enough labelling detail to precisely match every number to every specific time point, so some figures cannot be described with complete certainty. The trial measured these numbers but the results alone do not tell us whether any change was meaningful or how individuals might respond differently. 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.