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Sponsored by: |
Shire Pharmaceutical Development |
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Information provided by: | Shire Pharmaceutical Development |
ClinicalTrials.gov Identifier: | NCT00545103 |
The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.
Condition | Intervention | Phase |
---|---|---|
Diverticulitis |
Drug: SPD476, MMX™ mesalazine, 1.2g extended release tablet Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Randomised, Double-Blind, Dose-Response, Stratified, Placebo-Controlled Study Evaluating the Safety and Efficacy of SPD476 Versus Placebo Over 104 Weeks in the Prevention of Recurrence of Diverticulitis. |
Estimated Enrollment: | 584 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: SPD476, MMX™ mesalazine, 1.2g extended release tablet
SPD476 1.2g administered Once Daily (QD)
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2: Experimental |
Drug: SPD476, MMX™ mesalazine, 1.2g extended release tablet
SPD476 2.4g administered Once Daily (QD)
|
3: Experimental |
Drug: SPD476, MMX™ mesalazine, 1.2g extended release tablet
SPD476 4.8g administered Once Daily (QD)
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4: Placebo Comparator |
Drug: Placebo
Placebo
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Shire Call Centre | +1 866 842 5335 |
Principal Investigator: | Jeffrey B. Raskin, M.D. | University of Miami Miller School of Medicine |
Responsible Party: | Shire ( Timothy Whitaker, M.D. ) |
Study ID Numbers: | SPD476-314 |
Study First Received: | October 16, 2007 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00545103 |
Health Authority: | United States: Food and Drug Administration |
Diverticulitis Mesalamine Recurrence |
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 |