At a glance
ClinicalIndex Comparison Record- ✓Documented diagnosis of ulcerative colitis by endoscopy, surgery, or x-ray
- ✓Mild to moderate disease with Disease Activity Index score ≥4 and ≤10
- ✓Must be treated with minimum 2g daily of oral 5-ASA for at least 4 weeks (unless intolerant)
- ✓At least 18 years of age
- ✕Severe ulcerative colitis with Disease Activity Index >10
- ✕Class III or IV congestive heart failure (NYHA classification)
- ✕Allergy to thiazolidinediones
- ✕Medical condition with expected survival <1 year
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Placebo-controlled Trial of Rosiglitazone for Treatment of Ulcerative Colitis
In Brief
A Phase 2 clinical trial evaluating Rosiglitazone and Placebo for Ulcerative Colitis and Inflammatory Bowel Disease. Completed, enrolled 105 participants across 13 sites.
Detailed Summary
This is a multicenter, randomized, double-blind, placebo-controlled study evaluating rosiglitazone: 4 mg tablets or placebo tablets administered orally twice daily for 12 weeks. The purpose of the study is to evaluate the efficacy and safety of rosiglitazone in the treatment of mild to moderately active ulcerative colitis. Disease activity will be measured using a standard disease activity index. Calculation of the index requires patients to undergo flexible sigmoidoscopy at the start of the study and at week 12.
Study Details
Timeline
Interventions
4mg orally twice daily for 12 weeks
pill that looks identical to rosiglitazone