Ulcerative Colitis Clinical Trial
Official title:
A Randomized, Placebo-controlled Trial of Rosiglitazone for Treatment of Ulcerative Colitis
Verified date | December 2017 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 105 |
Est. completion date | January 2008 |
Est. primary completion date | January 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Atlanta Gastroenterology Associates | Atlanta | Georgia |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Metropolitan Gastroenterology Group Practice/Chevy Chase Clinical Research | Chevy Chase | Maryland |
United States | University of Chicago Hospitals | Chicago | Illinois |
United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
United States | University Hospitals of Cleveland | Cleveland | Ohio |
United States | Atlantic Gastroenterology Associates | Egg Harbor Township | New Jersey |
United States | Maryland Digestive Diseases Research | Laurel | Maryland |
United States | University of Pennsylvania - Presbyterian Medical Center | Philadelphia | Pennsylvania |
United States | Minnesota Gastroenterology | Plymouth | Minnesota |
United States | Wake Research Associates | Raleigh | North Carolina |
United States | Capitol Gastroenterology Consultants | Silver Spring | Maryland |
United States | Avamar Center for Endoscopy | Warren | Ohio |
Lead Sponsor | Collaborator |
---|---|
James Lewis | GlaxoSmithKline, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Lewis JD, Lichtenstein GR, Deren JJ, Sands BE, Hanauer SB, Katz JA, Lashner B, Present DH, Chuai S, Ellenberg JH, Nessel L, Wu GD; Rosiglitazone for Ulcerative Colitis Study Group. Rosiglitazone for active ulcerative colitis: a randomized placebo-controll — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Improvement of Signs and Symptoms of UC at 12 Weeks | Mayo score decrease >=2 points adjusted for age and smoking status. | 12 weeks | |
Secondary | Number of Participants With Clinical Remission at 12 Weeks | Mayo Score <=2 at 12 weeks post intervention | 12 weeks | |
Secondary | Number of Participants With Endoscopic Remission at 12 Weeks | 12 weeks |
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