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

Otsuka

Status and phase

Terminated

Phase 2

Conditions

Colitis, Ulcerative

Treatments

Drug: OPC-6535(Tetomilast)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00317356

197-05-002

JapicCTI-060216

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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