Status:
COMPLETED
CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) Remission
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 ...
Detailed Description
Objective(s): 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 ul...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2007
Estimated Enrollment :
1725 Patients enrolled
Trial Details
Trial ID
NCT00092508
Start Date
May 1 2004
End Date
May 1 2007
Last Update
June 21 2007
Active Locations (26)
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1
Clinical Research Associates
Huntsville, Alabama, United States, 35801
2
West Gastroenterology Medical Group
Los Angeles, California, United States, 90045
3
Mark Lamet
Hollywood, Florida, United States, 33021
4
Borland-Groover Clinic
Jacksonville, Florida, United States, 32256