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

NCT ID: NCT00317369

Last Updated: 2021-02-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2007-08-31

Brief Summary

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.

Conditions

Crohn Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

OPC-6535(Tetomilast)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Katsuhisa Saito

Role: STUDY_DIRECTOR

Study Director, Division of New Product Evaluation and Development

Locations

Chubu Region, , Japan

Chugoku Region, , Japan

Hokkaido Region, , Japan

Kanto Region, , Japan

Kinki Region, , Japan

Kyushu Region, , Japan

Shikoku Region, , Japan

Touhoku Region, , Japan

Countries

Japan

Other Identifiers

JapicCTI-060217

Identifier Type: -

Identifier Source: secondary_id

197-05-001

Identifier Type: -

Identifier Source: org_study_id