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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 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.

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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.

Conditions Studied

Ulcerative Colitis Inflammatory Bowel Disease

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

FieldValue
Enrollment Target 105 participants
Start Date 2002-09
Est. Completion 2008-01
Phase Phase 2

Sponsor

James Lewis

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00065065

The ClinicalTrials.gov registry entry for NCT00065065 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (95% lower). The listed sponsor is James Lewis, which has 5 total studies on file at ClinicalTrials.gov.

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 reports 13 study locations spanning 9 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.