A Trial of Rosiglitazone for Ulcerative Colitis

Phase 2

Completed

• Conditions: Ulcerative Colitis; Inflammatory Bowel Disease
• Interventions: Drug: Placebo; Drug: Rosiglitazone

• Registration Number: NCT00065065
• Lead Sponsor: James Lewis

Brief 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.

Detailed Description

Ulcerative colitis is a disease characterized by inflammation (the changes that happen when tissues in the body are injured) of all or a portion of the large intestine. There is presently no medical cure for ulcerative colitis, although surgical removal of the colon would cure the disease. Ulcerative colitis is generally treated with medications against diarrhea and infection, medications which suppress the immune system (the body system that protects a person against foreign substances) or with surgery.

It is thought that the chronic inflammation associated with ulcerative colitis may be related to the release of certain chemicals produced by the body. Rosiglitazone has been shown to inhibit the production of some of these chemicals. The active component of rosiglitazone has also been shown to improve colitis in animal models of colitis. The purpose of this study is to evaluate the benefit of the drug for ulcerative colitis by comparing it to placebo.

This is a randomized controlled trial of rosiglitazone versus placebo in patients who have failed to respond to 5-ASA therapy. Participants will be randomized to receive either rosiglitazone 4mg bid or placebo bid twice daily for a total of 12 weeks. Disease activity will be measured using the Disease Activity Index (DAI) at visits 3 through 8. Additional outcomes measured will include histological disease activity (visits 3 and 7) and quality of life using the IBDQ (visits 3 through 8). The principle analyses will be an intent-to-treat analysis to examine the efficacy of rosiglitazone at a dose of 4mg twice daily compared to placebo to achieve a partial or complete response. Additionally, the change in NF-κB activation prior to and following therapy with either placebo or rosiglitazone will be examined using immunohistochemistry techniques.

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2003-07-16
• Study First Submitted QC: 2003-07-17
• Study First Posted: 2003-07-18
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2014-07-10
• Results First Submitted QC: 2014-12-01
• Results First Posted: 2014-12-02
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-14
• Last Update Posted: 2018-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	Identical in appearance to study drug taken twice daily for 12 weeks.
Rosiglitazone	Rosiglitazone	4 mg of rosiglitazone taken twice daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Improvement of Signs and Symptoms of UC at 12 Weeks	12 weeks	Mayo score decrease \>=2 points adjusted for age and smoking status.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Clinical Remission at 12 Weeks	12 weeks	Mayo Score \<=2 at 12 weeks post intervention
Number of Participants With Endoscopic Remission at 12 Weeks	12 weeks

Trial Locations

Locations (13)

Wake Research Associates; 🇺🇸 Raleigh, North Carolina, United States

Capitol Gastroenterology Consultants; 🇺🇸 Silver Spring, Maryland, United States

University Hospitals of Cleveland; 🇺🇸 Cleveland, Ohio, United States

University of Chicago Hospitals; 🇺🇸 Chicago, Illinois, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Atlantic Gastroenterology Associates; 🇺🇸 Egg Harbor Township, New Jersey, United States

Metropolitan Gastroenterology Group Practice/Chevy Chase Clinical Research; 🇺🇸 Chevy Chase, Maryland, United States

Avamar Center for Endoscopy; 🇺🇸 Warren, Ohio, United States

Atlanta Gastroenterology Associates; 🇺🇸 Atlanta, Georgia, United States

Maryland Digestive Diseases Research; 🇺🇸 Laurel, Maryland, United States

Minnesota Gastroenterology; 🇺🇸 Plymouth, Minnesota, United States

The Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

University of Pennsylvania - Presbyterian Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States