At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease
In Brief
A Phase 3 clinical trial evaluating Placebo and OPC-6535 for Crohn's Disease. Completed, enrolled 191 participants across 11 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
oral administration of placebo once-daily for 8 weeks
oral administration of OPC-6535 25 mg once-daily for 8 weeks
oral administration of OPC-6535 50 mg once-daily for 8 weeks