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Sponsored by: |
Otsuka Pharmaceutical Co., Ltd. |
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Information provided by: | Otsuka Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT00317369 |
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.
Condition | Intervention | Phase |
---|---|---|
Crohn Disease |
Drug: OPC-6535(Tetomilast) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Dose-Finding Study of OPC-6535 in Patients With Active Crohn's Disease |
Estimated Enrollment: | 60 |
Study Start Date: | May 2006 |
Study Completion Date: | August 2007 |
Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 16 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan | |
Hokkaido region, Japan | |
Touhoku region, Japan | |
Kanto region, Japan | |
Kinki region, Japan | |
Kyushu region, Japan | |
Shikoku region, Japan | |
Chubu region, Japan | |
Chugoku region, Japan |
Study Director: | Katsuhisa Saito | Study Director, Division of New Product Evaluation and Development |
Study ID Numbers: | 197-05-001, JapicCTI-060217 |
Study First Received: | April 21, 2006 |
Last Updated: | April 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00317369 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
OPC-6535 Crohn's disease |
Signs and Symptoms Digestive System Diseases Gastrointestinal Diseases Crohn Disease |
Inflammatory Bowel Diseases Gastroenteritis Intestinal Diseases |