Trials / Completed
CompletedNCT00064441
FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 375 (planned)
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and efficacy of the drug OPC-6535 compared to a placebo in patients with active Ulcerative Colitis. Depending on their response, participants will be offered the investigational medication for up to one year after the study's completion at select sites.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OPC-6535 Tablets (drug) |
Timeline
- Start date
- 2003-05-01
- Primary completion
- 2006-05-01
- Completion
- 2006-05-01
- First posted
- 2003-07-10
- Last updated
- 2012-05-10
Locations
23 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00064441. Inclusion in this directory is not an endorsement.