NCT00989573

A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease

A Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 191 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Placebo	oral administration of placebo once-daily for 8 weeks
DRUG	OPC-6535	oral administration of OPC-6535 25 mg once-daily for 8 weeks
DRUG	OPC-6535	oral administration of OPC-6535 50 mg once-daily for 8 weeks

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2009-10-05
• Last updated: 2021-04-06
• Results posted: 2021-04-06

Locations

11 sites across 2 countries: Japan, South Korea