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A Trial of Rosiglitazone for Ulcerative Colitis


A Randomized, Placebo-controlled Trial of Rosiglitazone for Treatment of Ulcerative Colitis




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 Status: Completed


Condition Intervention Phase
Ulcerative Colitis
Inflammatory Bowel Disease
Drug: rosiglitazone (Avandia) Phase 2

Verified by James Lewis June, 2013

Sponsored by: James Lewis
Information provided by: University of Pennsylvania identifier: NCT00065065

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States

James D Lewis, MD, MSCE., Study Director

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