Conditions: Colitis, Ulcerative
Keywords: OPC-6535 ulcerative colitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 43
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:

Interventions: intervention 1: OPC-6535(Tetomilast)
Intervention descriptions: intervention 1: None

Protocol document: