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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00092508
Recruitment Status : Completed
First Posted : September 28, 2004
Last Update Posted : June 21, 2007
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: OPC-6535 Drug: Asacol® Phase 3

Detailed Description:


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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1725 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase 3, Multi-Center, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25 mg QD and 50 mg QD of OPC-6335 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Ulcerative Colitis Remission
Study Start Date : May 2004
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00092508

  Hide Study Locations
United States, Alabama
Clinical Research Associates
Huntsville, Alabama, United States, 35801
United States, California
West Gastroenterology Medical Group
Los Angeles, California, United States, 90045
United States, Florida
Mark Lamet
Hollywood, Florida, United States, 33021
Borland-Groover Clinic
Jacksonville, Florida, United States, 32256
Advanced Gastroenterology Associates
Palm Harbor, Florida, United States, 34684
Florida Medical Clinic
Zephyrhills, Florida, United States, 33542
United States, Maryland
Digestive Disorders Associates
Annapolis, Maryland, United States, 21404
Metropolitan Gastroenterology Group
Chevy Cha, Maryland, United States, 20815
United States, Massachusetts
Coastal Research Associates
Braintree, Massachusetts, United States, 02184
United States, Michigan
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States, 48047
United States, Mississippi
Digestive Health Specialists, PA
Tupelo, Mississippi, United States, 38801
United States, Missouri
Center for Digestive and Liver Diseases
Mexico, Missouri, United States, 65265
United States, New Jersey
Atlantic Gastroenterology Associates, PA
Egg Harbor Township, New Jersey, United States, 08234
United States, New York
Long Island Clinical Research Associates
Great Neck, New York, United States, 11021
United States, North Carolina
Asheville Gastroenterology Associates
Asheville, North Carolina, United States, 28801
Charlotte Gastroenterology & Hepatology
Charlotte, North Carolina, United States, 28207
Bethany Medical Center
High Point, North Carolina, United States, 27262
Hanover Medical Specialists, PA
Wilmington, North Carolina, United States, 28401
United States, Ohio
GI & Liver Consultants
Dayton, Ohio, United States, 45440
United States, Oklahoma
Sooner Clinical Research
Oklahoma City, Oklahoma, United States, 73112
Healthcare Research Consultants
Tulsa, Oklahoma, United States, 74135
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Gastroenterology Associates
Kingsport, Tennessee, United States, 37660
United States, Texas
Gastroenterology Clinic of San Antonio
San Antonio, Texas, United States, 78229
United States, Utah
Advanced Research Institute
Ogden, Utah, United States, 84405
United States, Virginia
Richmond, Virginia, United States, 23149
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc. Identifier: NCT00092508     History of Changes
Other Study ID Numbers: 197-02-220
First Posted: September 28, 2004    Key Record Dates
Last Update Posted: June 21, 2007
Last Verified: June 2007

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Ulcerative Colitis Remission

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents