A Trial of Rosiglitazone for Ulcerative Colitis

Condition(s) targeted: Ulcerative Colitis; Inflammatory Bowel Disease

Intervention: rosiglitazone (Avandia) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Official(s) and/or principal investigator(s):
James D Lewis, MD, MSCE, Study Director, Affiliation: University of Pennsylvania

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.

Official title: A Randomized, Placebo-Controlled Trial of Rosiglitazone for Treatment of Ulcerative Colitis

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Improvement of signs and symptoms of UC at 12 weeks

Secondary outcome:

clinical remission at 12 weeks

endoscopic remission at 12 weeks

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Atlanta Gastroenterology Associates, Atlanta, Georgia 30342, United States

University of Chicago Hospitals, Chicago, Illinois 60637, United States

Maryland Digestive Diseases Research, Laurel, Maryland 20707, United States

Metropolitan Gastroenterology Group Practice/Chevy Chase Clinical Research, Chevy Chase, Maryland 20815, United States

Capitol Gastroenterology Consultants, Silver Spring, Maryland 20901, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

Minnesota Gastroenterology, Plymouth, Minnesota 55446, United States

Atlantic Gastroenterology Associates, Egg Harbor Twp, New Jersey 08234, United States

Wake Research Associates, Raleigh, North Carolina 27612, United States

The Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States

University Hospitals of Cleveland, Cleveland, Ohio 44106, United States

Avamar Center for Endoscopy, Warren, Ohio 44484, United States

University of Pennsylvania - Presbyterian Medical Center, Philadelphia, Pennsylvania 19104, United States

Starting date: September 2002
Last updated: March 31, 2008