Trials / Terminated
TerminatedNCT00317356
A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 43 (actual)
- Sponsor
- Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OPC-6535(Tetomilast) |
Timeline
- Start date
- 2006-05-01
- Primary completion
- 2007-08-01
- Completion
- 2007-08-01
- First posted
- 2006-04-24
- Last updated
- 2021-04-30
- Results posted
- 2021-04-30
Locations
8 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT00317356. Inclusion in this directory is not an endorsement.