Clinical trial
CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC)…
NCT00092508 · Otsuka Pharmaceutical Development & Commercialization, Inc., Industry · Completed
Key facts
| NCT number | NCT00092508 |
|---|---|
| Title | CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) Remission |
| 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 |
| Lead sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc., Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Intervention type | Drug |
| Interventions | OPC-6535, Asacol® |
| Enrollment | 1,725 |
| Start date | May 1, 2004 |
| Completion | May 1, 2007 |
| First posted | Sep 28, 2004 |
| Last update posted | Jun 21, 2007 |
| Countries | United States |
At a glance
- 10–99 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: