A Trial of Rosiglitazone for Ulcerative Colitis
Condition: Ulcerative Colitis; Inflammatory Bowel Disease
MeSH terms: Colitis; Colitis, Ulcerative; Inflammatory Bowel Diseases; Ulcer
Intervention: Rosiglitazone; Placebo
Intervention description: 4mg orally twice daily for 12 weeks; pill that looks identical to rosiglitazone
Intervention MeSH terms: Rosiglitazone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Rosiglitazone; Ulcerative; Colitis

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.
    

Eligibility 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 (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/cu.mm, Platelets <75,000 per uL, INR > 1.2

          -  Participant is female and is pregnant or currently breastfeeding