A Trial of Rosiglitazone for Ulcerative Colitis
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.
Timeline
- Start
- 2002-09
- Primary completion
- 2008-01
- Completion
- 2008-01
Outcome
Met primary endpoint
paper 23 patients (44%) treated with rosiglitazone and 12 patients (23%) treated with placebo achieved clinical response (P = .04). PMID 18325386 ↗
registry Rosiglitazone; p = .005; Odds Ratio (OR) 4.0 (95% CI 1.5 to 10.5); Regression, Logistic NCT00065065 ↗
Publications
- Results Lewis JD, Lichtenstein GR, Deren JJ, Sands BE, Hanauer SB, Katz JA, Lashner B, Present DH, Chuai S, Ellenberg JH, Nessel L, Wu GD; Rosiglitazone for Ulcerative Colitis Study Group. Rosiglitazone for active ulcerative colitis: a randomized placebo-controlled trial. Gastroenterology. 2008 Mar;134(3):688-95. doi: 10.1053/j.gastro.2007.12.012. Epub 2007 Dec 7.
- Lewis JD, Chuai S, Nessel L, Lichtenstein GR, Aberra FN, Ellenberg JH. Use of the noninvasive components of the Mayo score to assess clinical response in ulcerative colitis. Inflamm Bowel Dis. 2008 Dec;14(12):1660-6. doi: 10.1002/ibd.20520.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rosiglitazone | Small molecule | 4 mg | Oral |