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A Trial of Rosiglitazone for Ulcerative Colitis
This study has been completed.
First Received: July 16, 2003   Last Updated: March 31, 2008   History of Changes
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator: 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

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

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Improvement of signs and symptoms of UC at 12 weeks

Secondary Outcome Measures:
  • clinical remission at 12 weeks
  • endoscopic remission at 12 weeks

Estimated Enrollment: 176
Study Start Date: September 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

INCLUSION CRITERIA: Participants must meet the following criteria for inclusion in the trial:

  • Must sign and date the informed consent form
  • At least 18 years of age
  • Documented diagnosis (endoscopic, surgical or x-ray) of ulcerative colitis
  • Mild to moderate ulcerative colitis indicated by Disease Activity Index score of greater than or equal to 4 and less than or equal to 10
  • Unless the patient is intolerant of oral 5-ASA therapy, patient must be treated with a minimum of 2 gm daily of an oral 5-ASA agent for a minimum of 4 weeks during the current exacerbation of ulcerative colitis or immediately prior to study entry
  • If treated with oral corticosteroids, dose must not exceed 20 mg per day of Prednisone or equivalent
  • If treated with corticosteroids, dose must be stable for 4 weeks prior to study entry and remain on same dose throughout
  • If treated with 6-mercaptopurine or azathioprine, must have been on medication for 4 months and a stable dose for 2 months prior to study entry
  • If a female of childbearing age, the participant must have a negative serum pregnancy test and have been using a medically approved form of contraceptive birth control for 3 months prior to enrollment. Participants, both male and female, must also be willing to use medically approved contraceptive birth control (at least one barrier method) throughout the study
  • If treated with rectal therapy, dose must be stable for 2 weeks prior to study entry and remain on same dose throughout

EXCLUSION CRITERIA: Participants will be ineligible for participation in the trial if they meet any of the following criteria:

  • Severe ulcerative colitis indicated by Disease Activity Index score of greater than 10
  • Class III or IV congestive heart failure by NYHA classification system
  • Allergy to thiozolidinediones
  • Presence of any medical condition with an expected survival of less than 1 year
  • Participants receiving therapy with cyclosporin, anti-TNF therapy, or methotrexate within the last 2 months of screening
  • Positive stool culture for enteric pathogens (salmonella, shigella, and campylobacter), positive C.difficil toxin, or positive stool ova and parasite exam
  • Positive proteinuria by urine dipstick
  • History of chronic liver disease or baseline liver chemistries greater than the upper limit of normal
  • Diabetes mellitus requiring hypoglycemic agents
  • Participation in study of experimental therapy within 2 months of first screening visit
  • Has any of the following laboratory abnormalities: WBC < 3,000 per uL, Neutrophil < 1,000 cell/cu.mm, Platelets <75,000 per uL, INR > 1.2
  • Participant is female and is pregnant or currently breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00065065

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
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: James D Lewis, MD, MSCE University of Pennsylvania
  More Information

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Study ID Numbers: ROSIE
Study First Received: July 16, 2003
Last Updated: March 31, 2008
ClinicalTrials.gov Identifier: NCT00065065     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Rosiglitazone
Ulcerative
Colitis

Additional relevant MeSH terms:
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Physiological Effects of Drugs
Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Pharmacologic Actions
Digestive System Diseases
Pathologic Processes
Hypoglycemic Agents
Gastroenteritis
Colitis
Rosiglitazone

ClinicalTrials.gov processed this record on November 27, 2009