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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

191

Participants

Timeline

Start Date

October 31, 2009

Primary Completion Date

August 31, 2012

Study Completion Date

August 31, 2012

Conditions
Crohn's Disease
Interventions
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

Trial Locations (11)

Unknown

Chubu Region

Chugoku Region

Hokkaido Region

Kanto Region

Kinki Region

Kyushu Region

Tohoku Region

Busan

Daegu

Gyronggi-do

Seoul

All Listed Sponsors
lead

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY