drugset / Trial / NCT00064441
FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2003-05
- Primary completion
- 2006-05
- Completion
- 2006-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tetomilast | Small molecule | — | — |