Ulcerative Colitis Clinical Trial
Official title:
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.
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.
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