A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease
Status:
Completed
Trial end date:
2012-08-01
Target enrollment:
Participant gender:
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.