|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) GlaxoSmithKline |
| Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| 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 |
| Genetics Home Reference related topics: | Crohn disease |
| MedlinePlus related topics: | Ulcerative Colitis |
| Drug Information available for: | Rosiglitazone Rosiglitazone Maleate |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomized, Placebo-Controlled Trial of Rosiglitazone for Treatment of Ulcerative Colitis |
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 | |||||
| Maryland Digestive Diseases Research | |||||
| Laurel, Maryland, United States, 20707 | |||||
| Metropolitan Gastroenterology Group Practice/Chevy Chase Clinical Research | |||||
| Chevy Chase, Maryland, United States, 20815 | |||||
| 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
| Study ID Numbers: | ROSIE |
| First Received: | July 16, 2003 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00065065 |
| Health Authority: | United States: Federal Government |
|
|
|
|