Conditions: Crohn's Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 191
Healthy volunteers: no

Brief summary:
The purpose of this study is to verify the safety and efficacy of OPC-6535 and determine the optimal dose by once-daily oral administration of OPC-6535 at 25 or 50 mg or placebo for 8 weeks in combination with base treatment (either a fixed oral dose of 5-aminosalicylic acid \[5-ASA\] or a fixed oral dose of 5-ASA plus enteral nutrition) in 180 patients with active Crohn's disease.

Detailed description:

Arms:
arm 1: oral administration of placebo once-daily for 8weeks arm 2: oral administration of OPC-6535 25 mg once-daily for 8 weeks arm 3: oral administration of OPC-6535 50mg once-daily for 8 weeks

Interventions: intervention 1: Placebo intervention 2: OPC-6535 intervention 3: OPC-6535
Intervention descriptions: intervention 1: oral administration of placebo once-daily for 8 weeks intervention 2: oral administration of OPC-6535 25 mg once-daily for 8 weeks intervention 3: oral administration of OPC-6535 50 mg once-daily for 8 weeks

Protocol document: