drugset / Trial / NCT00317356
A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to examine the safety and efficacy of OPC-6535 (tetomilast) and to determine its optimal dose by once-daily oral administration at 0, 12.5, 25, or 50 mg for 8 weeks in combination with a fixed oral dose of 5-aminosalicylic acid (5-ASA) in patients with active ulcerative colitis.
Timeline
- Start
- 2006-05
- Primary completion
- 2007-08
- Completion
- 2007-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tetomilast | Small molecule | 0 mg | Oral |
| Subject | Tetomilast | Small molecule | 12.5 mg | Oral |
| Subject | Tetomilast | Small molecule | 25 mg | Oral |
| Subject | Tetomilast | Small molecule | 50 mg | Oral |