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

Otsuka

Status and phase

Terminated

Phase 2

Conditions

Crohn Disease

Treatments

Drug: OPC-6535(Tetomilast)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00317369

197-05-001

JapicCTI-060217

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

All

Ages

16 to 65 years old

Volunteers

No Healthy Volunteers

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