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Sponsored by: |
Shire Pharmaceutical Development |
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Information provided by: | Shire Pharmaceutical Development |
ClinicalTrials.gov Identifier: | NCT00545740 |
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: | November 2007 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: SPD476, MMX™ mesalazine, 1.2g extended release tablet
1.2g SPD476/day QD
|
2: Experimental |
Drug: SPD476, MMX™ mesalazine, 1.2g extended release tablet
2.4g SPD476/day QD
|
3: Experimental |
Drug: SPD476, MMX™ mesalazine, 1.2g extended release tablet
4.8g SPD476/day QD
|
4: Placebo Comparator |
Drug: placebo
placebo
|
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: | Prof. Michael Kamm | St. Vincent’s Hospital. |
Responsible Party: | Shire ( Timothy Whitaker, M.D. ) |
Study ID Numbers: | SPD476-313 |
Study First Received: | October 16, 2007 |
Last Updated: | April 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00545740 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anti-Inflammatory Agents Diverticulitis Analgesics, Non-Narcotic Mesalamine Anti-Inflammatory Agents, Non-Steroidal |
Peripheral Nervous System Agents Analgesics Antirheumatic Agents Recurrence |
Anti-Inflammatory Agents Mesalamine Physiological Effects of Drugs Pharmacologic Actions Diverticulitis Pathologic Processes Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |