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Sponsored by: |
Otsuka Pharmaceutical Co., Ltd. |
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Information provided by: | Otsuka Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT00317356 |
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.
Condition | Intervention | Phase |
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Colitis, Ulcerative |
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 Ulcerative Colitis |
Estimated Enrollment: | 160 |
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: | 18 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 | |
Chubu region, Japan | |
Kyushu region, Japan | |
Chugoku region, Japan | |
Shikoku region, Japan | |
Kinki region, Japan |
Study Director: | Katsuhisa Saito | Division of New Product Evaluation and Development |
Study ID Numbers: | 197-05-002, JapicCTI-060216 |
Study First Received: | April 21, 2006 |
Last Updated: | April 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00317356 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
OPC-6535 ulcerative colitis |
Signs and Symptoms Digestive System Diseases Gastrointestinal Diseases Ulcer Colonic Diseases |
Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |
Pathologic Processes |