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A Trial of Rosiglitazone for Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00065065
Recruitment Status : Completed
First Posted : July 18, 2003
Results First Posted : December 2, 2014
Last Update Posted : January 16, 2018
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
James Lewis, University of Pennsylvania

Brief 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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Inflammatory Bowel Disease Drug: Rosiglitazone Drug: Placebo Phase 2

Detailed Description:

Ulcerative colitis is a disease characterized by inflammation (the changes that happen when tissues in the body are injured) of all or a portion of the large intestine. There is presently no medical cure for ulcerative colitis, although surgical removal of the colon would cure the disease. Ulcerative colitis is generally treated with medications against diarrhea and infection, medications which suppress the immune system (the body system that protects a person against foreign substances) or with surgery.

It is thought that the chronic inflammation associated with ulcerative colitis may be related to the release of certain chemicals produced by the body. Rosiglitazone has been shown to inhibit the production of some of these chemicals. The active component of rosiglitazone has also been shown to improve colitis in animal models of colitis. The purpose of this study is to evaluate the benefit of the drug for ulcerative colitis by comparing it to placebo.

This is a randomized controlled trial of rosiglitazone versus placebo in patients who have failed to respond to 5-ASA therapy. Participants will be randomized to receive either rosiglitazone 4mg bid or placebo bid twice daily for a total of 12 weeks. Disease activity will be measured using the Disease Activity Index (DAI) at visits 3 through 8. Additional outcomes measured will include histological disease activity (visits 3 and 7) and quality of life using the IBDQ (visits 3 through 8). The principle analyses will be an intent-to-treat analysis to examine the efficacy of rosiglitazone at a dose of 4mg twice daily compared to placebo to achieve a partial or complete response. Additionally, the change in NF-κB activation prior to and following therapy with either placebo or rosiglitazone will be examined using immunohistochemistry techniques.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled Trial of Rosiglitazone for Treatment of Ulcerative Colitis
Study Start Date : September 2002
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Rosiglitazone
4 mg of rosiglitazone taken twice daily for 12 weeks.
Drug: Rosiglitazone
4mg orally twice daily for 12 weeks
Other Name: Avandia

Placebo Comparator: placebo
Identical in appearance to study drug taken twice daily for 12 weeks.
Drug: Placebo
pill that looks identical to rosiglitazone

Primary Outcome Measures :
  1. Number of Participants With Improvement of Signs and Symptoms of UC at 12 Weeks [ Time Frame: 12 weeks ]
    Mayo score decrease >=2 points adjusted for age and smoking status.

Secondary Outcome Measures :
  1. Number of Participants With Clinical Remission at 12 Weeks [ Time Frame: 12 weeks ]
    Mayo Score <=2 at 12 weeks post intervention

  2. Number of Participants With Endoscopic Remission at 12 Weeks [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 (UC)
  • 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 thiazolidinediones
  • 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.difficile 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/, Platelets <75,000 per uL, INR > 1.2
  • Participant is female and is pregnant or currently breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00065065

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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 Township, New Jersey, United States, 08234
United States, North Carolina
Wake Research Associates
Raleigh, North Carolina, United States, 27612
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
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
James Lewis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Study Director: James D Lewis, MD, MSCE University of Pennsylvania
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: James Lewis, Professor of Medicine and Epidemiology, University of Pennsylvania Identifier: NCT00065065    
Other Study ID Numbers: ROSIE
R01DK059961 ( U.S. NIH Grant/Contract )
First Posted: July 18, 2003    Key Record Dates
Results First Posted: December 2, 2014
Last Update Posted: January 16, 2018
Last Verified: December 2017
Keywords provided by James Lewis, University of Pennsylvania:
Additional relevant MeSH terms:
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Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Hypoglycemic Agents
Physiological Effects of Drugs