Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2007

Intervention(s) in this Clinical Trial

• Drug: OPC-6535(Tetomilast)

Primary Measures

• Clinical improvement rate (number of patients showing clinical improvement/number of patients evaluated x 100) after 8 weeks of study drug administration

Secondary Measures

• Clinical improvement rate after 2 and 4 weeks of study drug administration
• Remission rate (number of patients showing remission/number of patients evaluated x 100) after 2, 4, and 8 weeks of study drug administration
• Improvement rate by change in total CDAI score (number of patients for each change/number of patients evaluated x 100) after 2, 4, and 8 weeks of study drug administration
• Mean change in total CDAI score after 2, 4, and 8 weeks of study drug administration
• Mean change from the baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score after 8 weeks of study drug administration
• Mean change from the baseline in CDEIS score after 8 weeks of study drug administration
• Time course of mean CRP level and mean change in CRP level from the baseline after 4 and 8 weeks of study drug administration

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Overall Clinical Trial Officials and Contacts

Katsuhisa Saito Study Director Study Director, Division of New Product Evaluation and Development  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00317369

Study ID Number: 197-05-001

ClinicalTrials.gov Identifier: NCT00317369

Health Authority: Japan: Ministry of Health, Labor and Welfare