CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) Remission
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
1 other identifier
interventional
1,725
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2004
Typical duration for phase_3
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 22, 2004
CompletedFirst Posted
Study publicly available on registry
September 28, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedJune 21, 2007
June 1, 2007
September 22, 2004
June 19, 2007
Conditions
Keywords
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Clinical Research Associates
Huntsville, Alabama, 35801, United States
West Gastroenterology Medical Group
Los Angeles, California, 90045, United States
Mark Lamet
Hollywood, Florida, 33021, United States
Borland-Groover Clinic
Jacksonville, Florida, 32256, United States
Advanced Gastroenterology Associates
Palm Harbor, Florida, 34684, United States
Florida Medical Clinic
Zephyrhills, Florida, 33542, United States
Digestive Disorders Associates
Annapolis, Maryland, 21404, United States
Metropolitan Gastroenterology Group
Chevy Cha, Maryland, 20815, United States
Coastal Research Associates
Braintree, Massachusetts, 02184, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047, United States
Digestive Health Specialists, PA
Tupelo, Mississippi, 38801, United States
Center for Digestive and Liver Diseases
Mexico, Missouri, 65265, United States
Atlantic Gastroenterology Associates, PA
Egg Harbor, New Jersey, 08234, United States
Long Island Clinical Research Associates
Great Neck, New York, 11021, United States
Asheville Gastroenterology Associates
Asheville, North Carolina, 28801, United States
Charlotte Gastroenterology & Hepatology
Charlotte, North Carolina, 28207, United States
Bethany Medical Center
High Point, North Carolina, 27262, United States
Hanover Medical Specialists, PA
Wilmington, North Carolina, 28401, United States
GI & Liver Consultants
Dayton, Ohio, 45440, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112, United States
Healthcare Research Consultants
Tulsa, Oklahoma, 74135, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Gastroenterology Associates
Kingsport, Tennessee, 37660, United States
Gastroenterology Clinic of San Antonio
San Antonio, Texas, 78229, United States
Advanced Research Institute
Ogden, Utah, 84405, United States
McGuire DVAMC
Richmond, Virginia, 23149, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 22, 2004
First Posted
September 28, 2004
Study Start
May 1, 2004
Study Completion
May 1, 2007
Last Updated
June 21, 2007
Record last verified: 2007-06