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| Sponsor: | University of Pennsylvania |
|---|---|
| Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) GlaxoSmithKline |
| Information provided by: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00065065 |
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ulcerative Colitis Inflammatory Bowel Disease |
Drug: rosiglitazone (Avandia) |
Phase II |
| 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 |
| Official Title: | A Randomized, Placebo-controlled Trial of Rosiglitazone for Treatment of Ulcerative Colitis |
| Enrollment: | 105 |
| Study Start Date: | September 2002 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Rosiglitazone |
Drug: rosiglitazone (Avandia)
4mg orally twice daily
|
| Placebo Comparator: placebo |
Drug: rosiglitazone (Avandia)
4mg orally twice daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
INCLUSION CRITERIA: Participants must meet the following criteria for inclusion in the trial:
EXCLUSION CRITERIA: Participants will be ineligible for participation in the trial if they meet any of the following criteria:
Contacts and Locations| United States, Georgia | |
| Atlanta Gastroenterology Associates | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Illinois | |
| University of Chicago Hospitals | |
| Chicago, Illinois, United States, 60637 | |
| United States, Maryland | |
| Metropolitan Gastroenterology Group Practice/Chevy Chase Clinical Research | |
| Chevy Chase, Maryland, United States, 20815 | |
| Maryland Digestive Diseases Research | |
| Laurel, Maryland, United States, 20707 | |
| Capitol Gastroenterology Consultants | |
| Silver Spring, Maryland, United States, 20901 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Minnesota | |
| Minnesota Gastroenterology | |
| Plymouth, Minnesota, United States, 55446 | |
| United States, New Jersey | |
| Atlantic Gastroenterology Associates | |
| Egg Harbor Twp, New Jersey, United States, 08234 | |
| United States, North Carolina | |
| Wake Research Associates | |
| Raleigh, North Carolina, United States, 27612 | |
| United States, Ohio | |
| The Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| University Hospitals of Cleveland | |
| Cleveland, Ohio, United States, 44106 | |
| Avamar Center for Endoscopy | |
| Warren, Ohio, United States, 44484 | |
| United States, Pennsylvania | |
| University of Pennsylvania - Presbyterian Medical Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Study Director: | James D Lewis, MD, MSCE | University of Pennsylvania |
More Information
| Responsible Party: | James Lewis, University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00065065 History of Changes |
| Other Study ID Numbers: | ROSIE, R01DK059961 |
| Study First Received: | July 16, 2003 |
| Last Updated: | May 6, 2011 |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
|
Rosiglitazone Ulcerative Colitis |
|
Colitis Colitis, Ulcerative Inflammatory Bowel Diseases Intestinal Diseases Ulcer Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Pathologic Processes Rosiglitazone Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |