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Sponsored by: |
Procter and Gamble |
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Information provided by: | Procter and Gamble |
ClinicalTrials.gov Identifier: | NCT00577473 |
The purpose of this study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) versus Asacol 2.4 g/day (400 mg tablet
Condition | Intervention | Phase |
---|---|---|
Ulcerative Colitis |
Drug: mesalamine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Randomized, 6 Week, Parallel-Group Design Clinical Trial in Patients With Mildly to Moderately Active Ulcerative Colitis to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day |
Enrollment: | 308 |
Study Start Date: | February 2001 |
Study Completion Date: | February 2003 |
Primary Completion Date: | February 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
mesalamine 2.4 g/day (400 mg tablet) for 6 weeks
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Drug: mesalamine
mesalamine 2.4 g/day (400 mg tablet) for 6 weeks
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2: Experimental
mesalamine 4.8 g/day (800 mg tablet) for 6 weeks
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Drug: mesalamine
mesalamine 4.8 g/day (800 mg tablet) for 6 weeks
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This study is designed to evaluate the safety and efficacy of 4.8 g/day using 800 mg Asacol tablets as compared to 2.4g/day using 400 mg Asacol tablets in newly- and previously-diagnosed patients who are experiencing a flare-up of mildly to moderately active ulcerative colitis.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Jeffery Kralstein, MD | Procter and Gamble |
Responsible Party: | Procter and Gamble ( Piotr Krzeski, MD ) |
Study ID Numbers: | 2000083 |
Study First Received: | December 19, 2007 |
Last Updated: | February 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00577473 |
Health Authority: | United States: Food and Drug Administration |
Digestive System Diseases Mesalamine Gastrointestinal Diseases Ulcer Colonic Diseases |
Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |
Anti-Inflammatory Agents Pathologic Processes Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs |
Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents Pharmacologic Actions |