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CORE: A Study of OPC-6535 with Asacol® in Maintaining Ulcerative Colitis (UC) Remission
This study is currently recruiting patients.
| Sponsored by: | Otsuka Maryland Research Institute |
|---|---|
| Information provided by: | Otsuka Maryland Research Institute |
Purpose
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 | Treatment or Intervention | Phase |
|---|---|---|
| Ulcerative Colitis |
Drug: OPC-6535 Drug: Asacol® |
Phase III |
MedlinePlus related topics: Ulcerative Colitis
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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
Expected Total Enrollment: 1725
Study start: May 2004;
Study completion: May 2007
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 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.
Eligibility
Ages Eligible for Study: 18 Years - 80 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
Exclusion Criteria:
Location
and Contact
Information
More Information
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