A Dose-finding Study of OPC-6535 in Patients With Active Crohn's Disease

A Dose-finding Study of OPC-6535 in Patients With Active Crohn's Disease

The purpose of this study to examine the safety and efficacy of OPC-6535 and determine its optimal dose by once-daily oral administration at 0, 25, or 50 mg for 8 weeks in combination with a fixed oral dose of 5-aminosalicylic acid (5-ASA) or in combination with a fixed oral dose of 5-ASA and enteral nutrition in patients with active Crohn's disease.

Inclusion Criteria:

• Patients with active Crohn's disease
• Patients who have a primary lesion in either the small intestine or the large intestine
• Patients who have been receiving an oral 5-ASA formulation at a fixed regimen and at a fixed dose
• Patients who have either never received enteral nutrition or have been receiving enteral nutrition at a fixed intake of 1200 kcal/day or less
• Either inpatient or outpatient

Exclusion Criteria:

• Patients who have an external fistula (including anal fistula) in which persistent drainage is observed (and who require treatment with antibiotics or synthetic antibacterial agents)
• Patients with short bowel syndrome (and who require intravenous nutritional support due to insufficient intestinal nutrient uptake)
• Patients with an artificial anus
• Patients who have a complication of serious infectious disease (intra-abdominal abscess, etc.)
• Patients who have a complication of malignant tumor
• Female patients who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the study period