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

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.

Inclusion Criteria:

• Primary lesion in either small intestine or large intestine
• C-reactive protein (CRP) level above the upper limit of the normal range
• Patients who have been receiving a 5-ASA formulation (oral mesalazine) at a fixed dose of 2.25 g/day or higher (not exceeding the approved dose) and at a fixed dosing regimen
• Patients who have not received enteral nutrition or who have been receiving enteral nutrition at a fixed intake of 1200 kcal/day or less

Exclusion Criteria:

• Patients with an uncontrolled external fistula (including anal fistula)
• Patients with a history of total proctocolectomy or subtotal colectomy
• Patients with short bowel syndrome
• Patients with an artificial anus
• Patients with serious infectious disease (intra-abdominal abscess, etc)
• Patients with malignant tumor
• Female patients who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the trial period