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Sponsored by: |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
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Information provided by: | Otsuka Pharmaceutical Development & Commercialization, Inc. |
ClinicalTrials.gov Identifier: | NCT00092508 |
This dose comparison study, taking place at over 200 sites worldwide, will compare the dosing, safety and efficacy of an investigational medicine OPC-6535 to the dosing, safety and efficacy of Asacol ® in the maintenance of remission in subjects with ulcerative colitis.
Condition | Intervention | Phase |
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Ulcerative Colitis |
Drug: OPC-6535 Drug: Asacol® |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 3, Multi-Center, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25 mg QD and 50 mg QD of OPC-6335 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Ulcerative Colitis Remission |
Estimated Enrollment: | 1725 |
Study Start Date: | May 2004 |
Estimated Study Completion Date: | May 2007 |
Objective(s):
This study will compare the safety and efficacy of 25 mg per day (QD) and 50 mg QD of OPC-6535 to 800 mg twice a day (BID) of Asacol® in the maintenance of remission in subjects with ulcerative colitis.
Subject Population:
Safety: Vital signs, ECGs, laboratory studies (including hematology, clinical chemistry, and urinalysis), and adverse events.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
NOTE: During the study, use of these drugs will be discontinued.
Exclusion Criteria:
Study ID Numbers: | 197-02-220 |
Study First Received: | September 22, 2004 |
Last Updated: | June 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00092508 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Ulcerative Colitis Remission ulcerative colitis remission relapse Asacol® |
maintain maintenance flare rectal bleeding bowel |
Anti-Inflammatory Agents Gastrointestinal Diseases Mesalamine Ulcer Colonic Diseases Benzocaine Inflammatory Bowel Diseases Colitis, Ulcerative Hemorrhage |
Intestinal Diseases Digestive System Diseases Analgesics, Non-Narcotic Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Gastroenteritis Colitis |
Anti-Inflammatory Agents Gastrointestinal Diseases Mesalamine Ulcer Physiological Effects of Drugs Colonic Diseases Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases Pharmacologic Actions Digestive System Diseases |
Pathologic Processes Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Gastroenteritis Central Nervous System Agents Colitis |