Official Title: “A Randomized, Placebo-Controlled Trial of Rosiglitazone for Treatment of 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 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.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: rosiglitazone (Avandia)

Primary Measures

• Improvement of signs and symptoms of UC at 12 weeks

Secondary Measures

• clinical remission at 12 weeks
• endoscopic remission at 12 weeks

• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Overall Clinical Trial Officials and Contacts

James D Lewis, MD, MSCE Study Director University of Pennsylvania  

Information obtained from ClinicalTrials.gov on August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00065065

Study ID Number: ROSIE

ClinicalTrials.gov Identifier: NCT00065065

Health Authority: United States: Federal Government