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Sponsored by: |
Shire Pharmaceutical Development |
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Information provided by: | Shire Pharmaceutical Development |
ClinicalTrials.gov Identifier: | NCT00446849 |
To evaluate the percentage of subjects with clinical recurrence at 6 months.
Condition | Intervention | Phase |
---|---|---|
Ulcerative Colitis |
Drug: MMX Mesalamine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase IV, Multi-Center, Open-Label Study to Assess Clinical Recurrence Related to Compliance With Treatment With MMXÔ Mesalamine 2.4g/Day Given Once Daily for the Maintenance of Quiescent Ulcerative Colitis (UC) |
Estimated Enrollment: | 360 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: MMX Mesalamine
MMX™ mesalamine 2.4g/day to 4.8g/day QD (two to four 1.2g tablets MMX™ mesalamine, dosed QD,respectively).
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria - Acute Phase:
Inclusion Criteria - Maintenance Phase:
Exclusion Criteria - Acute Phase:
Exclusion Criteria - Maintenance Phase (in addition to above inclusion for the Acute Phase):
Principal Investigator: | Sunanda V. Kane, M.D. | Mayo Clinic, Rochester, MN |
Responsible Party: | Shire Pharmaceutical ( Timothy Whitaker, M.D. ) |
Study ID Numbers: | SPD476-404 |
Study First Received: | March 12, 2007 |
Last Updated: | June 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00446849 |
Health Authority: | United States: Food and Drug Administration |
ulcerative colitis compliance mesalamine clinical study clinical trial clinical research maintenance long term uc study |
uc trial uc research open label once a day once daily daily dosing simple oral |
Digestive System Diseases Mesalamine Gastrointestinal Diseases Ulcer Colonic Diseases Inflammatory Bowel Diseases |
Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis 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 |