A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis

A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis

The purpose of this study is to examine the safety and efficacy of OPC-6535 (tetomilast) and to determine its optimal dose by once-daily oral administration at 0, 12.5, 25, or 50 mg for 8 weeks in combination with a fixed oral dose of 5-aminosalicylic acid (5-ASA) in patients with active ulcerative colitis.

Inclusion Criteria:

• Patients with active ulcerative colitis
• Patients who have been receiving an oral 5-ASA formulation at a fixed regimen and at a fixed dose
• Either inpatient or outpatient

Exclusion Criteria:

• Patients who have a history of intestinal resection (other than appendiceal resection)
• 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