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Sponsored by: |
Shire Pharmaceutical Development |
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Information provided by: | Shire Pharmaceutical Development |
ClinicalTrials.gov Identifier: | NCT00548574 |
The primary objective of the study was to compare the percentage of subjects in remission after 8 weeks of treatment with SPD476, 2.4 g/day once daily vs placebo and SPD476 4.8 g/day once daily versus placebo
Condition | Intervention | Phase |
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Ulcerative Colitis |
Drug: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine Drug: Mesalazine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Randomized, Multi-Centre, Double-Blind, Double Dummy, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to ASACOL 0.8g Three Times Daily, in Subjects With Mild to Moderate Ulcerative Colitis |
Enrollment: | 343 |
Study Start Date: | December 2003 |
Study Completion Date: | July 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
Imelda General Hospital Dept of Gastroenterology | |
Bonheiden, Belgium |
Principal Investigator: | Professor Michael Kamm | St Marks Hospital, London, UK |
Study ID Numbers: | SPD476-302 |
Study First Received: | October 23, 2007 |
Last Updated: | July 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00548574 |
Health Authority: | France: Institutional Ethical Committee |
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 |