CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) Remission
NCT ID: NCT00092508
Last Updated: 2007-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1725 participants
INTERVENTIONAL
2004-05-31
2007-05-31
Brief Summary
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Detailed Description
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This study will compare the safety and efficacy of 25 mg per day (QD) and 50 mg QD of OPC-6535 to 800 mg twice a day (BID) of Asacol® in the maintenance of remission in subjects with ulcerative colitis.
Subject Population:
* Subjects with ulcerative colitis currently in remission defined as rectal bleeding (RB) and flexible sigmoidoscopy (FS) scores of 0, on or off a stable dose of sulfasalazine or 5-ASA products for at least 6 weeks.
* Subjects must have had the diagnosis of ulcerative colitis established by prior colonoscopy or undergo colonoscopy in lieu of flexible sigmoidoscopy during the Screening Period.
* Subjects must have had treatment for a flare of ulcerative colitis, with symptomatic onset of remission occurring no more than 52 weeks from the Screening Period.
* Subjects may not have used corticosteroids, topical agents (corticosteroid or 5-ASA enemas, suppositories, foams), azathioprine, 6-mercaptopurine, or methotrexate within 6 weeks of the Screening Period. Upon entry, sulfasalazine and 5-ASA containing products will be discontinued.
Safety: Vital signs, ECGs, laboratory studies (including hematology, clinical chemistry, and urinalysis), and adverse events.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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OPC-6535
Asacol®
Eligibility Criteria
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Inclusion Criteria
* Subjects with a prior diagnosis of ulcerative colitis, established by colonoscopy.
* Subjects currently in remission.
* Subjects who have undergone treatment for a flare of ulcerative colitis, with symptomatic onset of remission occurring no more than 52 weeks from the Screening Period.
* If subjects are taking sulfasalazine or 5-ASA products prior to entry, the dose must be stable for at least 6 weeks prior to the Screening Period. NOTE: During the study, use of these drugs will be discontinued.
* Subjects having undergone colonoscopy with pan-colonic surveillance biopsies negative for dysplasia within 1 year of the Screening Visit if at increased risk of colorectal cancer (≥ 8 year history of ulcerative colitis).
* Female or male subjects who are surgically sterilized or who are prepared to and agree to practice a double-barrier form of birth control from the Screening Period through 30 days (females) and 90 days (males), respectively, from the last dose of study medication. Females who are more than 12 months post-menopausal are also eligible to participate in the study.
Exclusion Criteria
* Subjects who have any other clinically significant disease(s) or condition/procedure(s).
* Subjects who have had major gastrointestinal surgery including, but not limited to, a colostomy, an ileostomy or previous colonic surgery other than appendectomy.
* Subjects who have used corticosteroids or topical agents (corticosteroid or 5-ASA enemas, suppositories, foams) within 6 weeks of the Screening Period.
* Female subjects who are pregnant or lactating.
18 Years
80 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Locations
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Clinical Research Associates
Huntsville, Alabama, United States
West Gastroenterology Medical Group
Los Angeles, California, United States
Mark Lamet
Hollywood, Florida, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
Advanced Gastroenterology Associates
Palm Harbor, Florida, United States
Florida Medical Clinic
Zephyrhills, Florida, United States
Digestive Disorders Associates
Annapolis, Maryland, United States
Metropolitan Gastroenterology Group
Chevy Cha, Maryland, United States
Coastal Research Associates
Braintree, Massachusetts, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States
Digestive Health Specialists, PA
Tupelo, Mississippi, United States
Center for Digestive and Liver Diseases
Mexico, Missouri, United States
Atlantic Gastroenterology Associates, PA
Egg Harbor, New Jersey, United States
Long Island Clinical Research Associates
Great Neck, New York, United States
Asheville Gastroenterology Associates
Asheville, North Carolina, United States
Charlotte Gastroenterology & Hepatology
Charlotte, North Carolina, United States
Bethany Medical Center
High Point, North Carolina, United States
Hanover Medical Specialists, PA
Wilmington, North Carolina, United States
GI & Liver Consultants
Dayton, Ohio, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, United States
Healthcare Research Consultants
Tulsa, Oklahoma, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Gastroenterology Associates
Kingsport, Tennessee, United States
Gastroenterology Clinic of San Antonio
San Antonio, Texas, United States
Advanced Research Institute
Ogden, Utah, United States
McGuire DVAMC
Richmond, Virginia, United States
Countries
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Other Identifiers
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197-02-220
Identifier Type: -
Identifier Source: org_study_id