Trial 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
According to the results reported on ClinicalTrials.gov, this trial (NCT01036022) enrolled 78 people in total across six groups. Fifteen people received a placebo (a dummy treatment with no active ingredient), sixteen received an existing medicine called Asacol, and the remaining 47 were split across four different dose levels of an investigational medicine called GSK1399686 (10 mg, 30 mg, 100 mg, and 300 mg — 11 to 12 people per dose group). Not everyone finished the study: across all groups, between 7 and 13 people per group completed it. The trial was primarily measuring a range of health monitoring information — including unwanted medical events, blood test results, urine tests, blood pressure, heart rate, and heart tracing (ECG) readings — rather than how well the treatment worked against a disease. The reported data shows that when it came to unwanted medical events (called adverse events), 10 out of 15 placebo participants, 7 out of 11 in the 10 mg group, 9 out of 12 in the 30 mg group, 6 out of 12 in the 100 mg group, 5 out of 12 in the 300 mg group, and 12 out of 16 in the Asacol group had at least one such event recorded. Serious adverse events (more significant medical occurrences) were reported for 1 person in the placebo group, 2 in the 10 mg group, and 1 in the Asacol group, with none reported in the three higher GSK1399686 dose groups. For blood chemistry results outside normal ranges, only small numbers of participants were flagged across groups (ranging from 0 to 1 per group depending on the measure). Similarly, for blood cell counts outside normal ranges, the numbers were small, ranging from 0 to 3 participants per group. Urine test abnormalities and vital sign readings outside defined ranges were also reported in only a small number of participants across the groups. For heart tracings (ECG), between 2 and 3 participants per group had some form of abnormal finding noted, with 1 to 2 per group having findings considered clinically significant. 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 full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Crohn's Disease and Colitis Trial, Completed
Who may be able to join
AI generated eligibility 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
Who might be able to join this trial:
- Adults between 18 and 65 years old (male or female) who are not able to become pregnant.
- People diagnosed with mild-to-moderately active ulcerative colitis that extends beyond the rectum, confirmed by symptoms and a camera examination of the bowel (endoscopy).
- People whose disease activity falls within a specific measured range, based on scores that include rectal bleeding and endoscopy findings (confirm with trial site for exact scoring details).
- People who weigh at least 50 kg and have a body mass index (BMI) between 18.5 and 29.9.
- People who are able to understand and sign a consent form, and are willing to follow the trial's requirements.
Who may not be able to join:
- People with a known allergy or sensitivity to any of the study medications, to a hormone called ACTH, or any other allergy that the study doctor considers a concern.
- People who have had a sensitivity reaction to a type of medication called 5-ASA, or who have kidney problems or kidney disease.
- People with a current or past history of asthma, or other serious allergic conditions.
- People with a current or past history of chronic liver disease, or known liver or bile duct problems (except for a harmless condition called Gilbert's syndrome or gallstones that cause no symptoms).
- People who have tested positive for Hepatitis B or Hepatitis C within the 3 months before screening.
- People with significant blood disorders, serious bleeding conditions, or immune system disorders.
- People with certain abnormal heart rhythm readings on an electrocardiogram (ECG) (confirm with trial site for exact measurements).
- People with a significant heart, lung, metabolic, infectious, or mental health condition that the study doctor believes poses an unacceptable safety risk.
- People who have had a cancer diagnosis in the past 5 years, except for certain localised skin cancers or early-stage cancers that have been fully removed.
- People who have regularly consumed alcohol in the 6 months before the study, or who currently misuse recreational drugs.
- People whose bowel inflammation is caused by a confirmed infection rather than ulcerative colitis.
- People where Crohn's disease or another type of colitis (such as microscopic, ischaemic, or radiation-induced colitis) is suspected, based on their medical history or test results.
- People who have had bowel surgery in the past 12 months.
- People who have used certain anti-inflammatory bowel medications (aminosalicylates) at higher doses by mouth, or at any dose as a topical treatment, within 2 weeks before the first study visit.
- People who have used steroid medications (by any route) within 4 weeks before the first study visit.
- People who have used biologic medications such as TNF-alpha inhibitors within 2 months before the first study visit.
- People who started or changed the dose of certain immune-suppressing medications (azathioprine or 6-mercaptopurine) within 3 months before the first study visit.
- People who started taking probiotic or prebiotic supplements regularly within 4 weeks before the first study visit.
- People who have regularly used anti-inflammatory pain medications (NSAIDs) within 7 days before the first study visit, except for low-dose aspirin taken for heart health.
- People who have taken certain medications known to strongly interact with the way the body processes drugs (strong CYP3A4/5 inducers, such as some seizure or antibiotic medications), or who regularly use St. John's Wort, within 14 days before the first study visit.
- People who have taken certain other medications known to strongly interact with drug processing (strong CYP3A4/5 inhibitors, such as certain antifungal or antibiotic medications), or who regularly drink grapefruit juice, within 7 days before the first study visit.
- People who have taken certain medications that are sensitive to drug processing interactions and have a narrow safe dosage range (such as certain heart or transplant medications) within 7 days before the first study visit (confirm with trial site for full list).
- People who have taken part in another clinical trial or received an experimental treatment within 30 days before the first study visit, or longer depending on the experimental product used.
- People who have previously been enrolled in this same trial.
- For Canadian trial locations only: People with existing stomach or small intestine ulcers, or with a blockage in the urinary tract.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
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Trial details
Where this trial is recruiting
Primary endpoints
Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE); Number of Participants With Clinical Chemistry Data Outside the Reference Range; Number of Participants With Hematology Data Outside the Reference Range; Number of Participants of Abnormal Urinalysis Dipstick Results; Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI); Number of Participants With Abnormal Electrocardiography (ECG) Findings; Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Com...
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Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.