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A Randomized Trial of Rosiglitazone for Ulcerative Colitis Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about A Randomized Trial of Rosiglitazone for Ulcerative Colitis conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Randomized Trial of Rosiglitazone for Ulcerative Colitis Clinical research trials and A Randomized Trial of Rosiglitazone for Ulcerative Colitis medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as A Randomized Trial of Rosiglitazone for Ulcerative Colitis. A Randomized Trial of Rosiglitazone for Ulcerative Colitis Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Randomized Trial of Rosiglitazone for Ulcerative Colitis clinical trial. Participants frequently get the best healthcare available for their A Randomized Trial of Rosiglitazone for Ulcerative Colitis condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Randomized Trial of Rosiglitazone for Ulcerative Colitis  A Randomized Trial of Rosiglitazone for Ulcerative Colitis
A Randomized Trial of Rosiglitazone for Ulcerative Colitis
For Condition: Inflammatory Bowel Disease,Ulcerative Colitis
Status: Recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) , GlaxoSmithKline
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 176
Location and Contact Information:
The Cleveland Clinic Foundation *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Amy Knesebeck 216-444-8539
Massachusetts General Hospital *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Marie Marcucci 617-724-7559
Maryland Digestive Diseases Research *Recruiting*
Laurel, Maryland, 20707
United States
Recruiting Meg Gordon 301-498-5500
Metropolitan Gastroenterology Group Practice/Chevy Chase Clinical Research *Recruiting*
Chevy Chase, Maryland, 20815
United States
Recruiting Tricia Reyes 301-652-5520
University of Chicago Hospitals *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting JoAnna Hitchcock 773-702-1935
University of Pennsylvania - Presbyterian Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Susan Parrott 215-662-8919
University Hospitals of Cleveland *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Laurie Logan 216-844-3878
Atlantic Gastroenterology Associates *Recruiting*
Egg Harbor Twp, New Jersey, 08234
United States
Recruiting Theresa Stevens 609-407-1220
Additional Information:
Study ID Numbers: ROSIE;
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00065065
Other Ulcerative Colitis Studies:
1. A pharmacokinetic study to determine the oral bioavailability of methotrexate in patients with inflammatory bowel disease
2. Clotrimazole Enemas for Pouchitis in Children and Adults
3. Humanized anti-IL-2 receptor monoclonal antibody in moderate-to-severe ulcerative colitis
4. Immune Regulation in Ulcerative Colitis or Crohn's Disease
5. A Randomized Trial of Rosiglitazone for Ulcerative Colitis
Related Studies:
Other Ulcerative Colitis Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
A Randomized Trial of Rosiglitazone for Ulcerative Colitis
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