CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) Remission

Completed · Phase 3

Conditions studied: Ulcerative Colitis

In brief

This dose comparison study, taking place at over 200 sites worldwide, will compare the dosing, safety and efficacy of an investigational medicine OPC-6535 to the dosing, safety and efficacy of Asacol ® in the maintenance of remission in subjects with ulcerative colitis.

Key facts

Study ID

NCT00092508

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

1725

Starts

2004-05-01

Expected to finish

2007-05-01

Last updated by the study team

2007-06-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects, 18 to 80 years of age, inclusive.
• 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.

You may not qualify if…

• Subjects who have active disease.
• 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.
• Other exclusion criteria may apply.

Where it is running

• 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

Full record on ClinicalTrials.gov

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