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NCT00065065 · ClinicalTrials.gov registry record · Phase 2
A Trial of Rosiglitazone for Ulcerative Colitis
A Phase 2 study of Ulcerative Colitis and Inflammatory Bowel Disease, sponsored by James Lewis.
- Completed
- Registry status
- Phase 2
- Development phase
- 105
- Enrollment target
- 13
- Study locations
NCT00065065: Completed Phase 2 study of Ulcerative Colitis and Inflammatory Bowel Disease, sponsored by James Lewis.
NCT00065065 is a Phase 2 study of Ulcerative Colitis and Inflammatory Bowel Disease that has completed, run by James Lewis. The registered enrollment target is 105 participants, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (95% lower). The trial reports 13 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00065065, a Phase 2 study of Ulcerative Colitis and Inflammatory Bowel Disease, has completed, sponsored by James Lewis.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 105 participants
- Enrollment target
- 13
- Study locations
Study 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.
Primary Outcome
Mayo score decrease \>=2 points adjusted for age and smoking status.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Rosiglitazone
Study Locations (13)
Maryland
- Metropolitan Gastroenterology Group Practice/Chevy Chase Clinical Research - Chevy Chase
- Maryland Digestive Diseases Research - Laurel
- Capitol Gastroenterology Consultants - Silver Spring
Ohio
- University Hospitals of Cleveland - Cleveland
- The Cleveland Clinic Foundation - Cleveland
- Avamar Center for Endoscopy - Warren
Georgia
- Atlanta Gastroenterology Associates - Atlanta
Illinois
- University of Chicago Hospitals - Chicago
Massachusetts
- Massachusetts General Hospital - Boston
Minnesota
- Minnesota Gastroenterology - Plymouth
New Jersey
- Atlantic Gastroenterology Associates - Egg Harbor
North Carolina
- Wake Research Associates - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2002-09 |
| Est. Completion | 2008-01 |
| Phase | Phase 2 |
What the finished NCT00065065 record still lists
NCT00065065 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00065065 lists 13 locations in 9 states (Maryland, Ohio, Georgia).
Frequently Asked Questions
What is clinical trial NCT00065065 about?
NCT00065065 is a clinical study titled "A Trial of Rosiglitazone for 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 ac...
What is the current status of trial NCT00065065?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2002-09. Estimated completion is 2008-01.
What conditions does trial NCT00065065 study?
This clinical trial studies the following conditions: Ulcerative Colitis, Inflammatory Bowel Disease.
What interventions are being tested in trial NCT00065065?
The interventions under investigation include: Placebo (DRUG), Rosiglitazone (DRUG).
Who is sponsoring clinical trial NCT00065065?
This trial is sponsored by James Lewis, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00065065 being conducted?
This trial has 13 study locations across Georgia, Illinois, Maryland, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ulcerative Colitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00065065's enrollment target sits among peer trials
105 65th of 122 higher than 58 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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