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...
Brief Summary
Official Title: “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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
- Study Primary Completion Date: August 2007
Intervention(s) in this Clinical Trial
- Drug: OPC-6535(Tetomilast)
Outcome Measures for this Clinical Trial
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
- Remission rate (number of patients showing remission/number of patients evaluated x 100) after 4 and 8 weeks of study drug administration
- Mean change from the baseline in total Disease Activity Index (DAI) score after 4 and 8 weeks of study drug administration
- Mean change from the baseline in DAI subscores after 4 and 8 weeks of study drug administration
- Mean change from the baseline in total Clinical Activity Index (CAI) 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 IBDQ subscale scores after 8 weeks of study drug administration
- Clinical improvement rate after 4 weeks of study drug administration
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Otsuka Pharmaceutical Co., Ltd. Industry
Overall Clinical Trial Officials and Contacts
Katsuhisa Saito Study Director Division of New Product Evaluation and Development
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00317356
Study ID Number: 197-05-002
ClinicalTrials.gov Identifier: NCT00317356
Health Authority: Japan: Ministry of Health, Labor and Welfare
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00317356
