Clinical trial
FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the…
NCT00064441 · Otsuka Pharmaceutical Development & Commercialization, Inc., Industry · Completed
Key facts
| NCT number | NCT00064441 |
|---|---|
| Title | FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis |
| Official title | FACTS I: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects With Active Ulcerative Colitis |
| 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 Tablets (drug) |
| Enrollment | 375 |
| Start date | May 1, 2003 |
| Primary completion | May 1, 2006 |
| Completion | May 1, 2006 |
| First posted | Jul 10, 2003 |
| Last update posted | May 10, 2012 |
| 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: