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Sponsored by: |
Shire Pharmaceutical Development |
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Information provided by: | Shire Pharmaceutical Development |
ClinicalTrials.gov Identifier: | NCT00503243 |
The aim of this study was to investigate the safety and efficacy of SPD476 2.4 g/day given twice daily ([BID] ie 1.2 g/day BID) and SPD476 4.8g/day given QD compared to placebo in subjects with acute, mild to moderate ulcerative colitis.
Condition | Intervention | Phase |
---|---|---|
Colitis, Ulcerative |
Drug: Delayed and extended release mesalazine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Randomized, Multi-Centre, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) Versus SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis |
Enrollment: | 280 |
Study Start Date: | September 2003 |
Study Completion Date: | August 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | SPD476-301 |
Study First Received: | July 16, 2007 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00503243 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anti-Inflammatory Agents Gastrointestinal Diseases Mesalamine Ulcer Colonic Diseases Inflammatory Bowel Diseases Colitis, Ulcerative 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 |