Study:
A Randomized, Placebo-controlled Trial of Rosiglitazone for Treatment of Ulcerative Colitis
Rationale:
n/a
Purpose:
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
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Ulcerative Colitis
Inflammatory Bowel Disease |
Drug: rosiglitazone (Avandia) |
Phase 2 |
Verified by
University of Pennsylvania
May, 2011
Sponsored by: University of Pennsylvania
Information provided by: University of Pennsylvania
ClinicalTrials.gov 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