Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis



Status:Archived
Conditions:Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:May 2010
End Date:July 2012

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A Phase 4, Open-label, Multicenter, Prospective Study to Evaluate the Effect of Remission Status on the Ability to Maintain or Achieve Clinical and Endoscopic Remission During a 12-Month, Long-term Maintenance Phase With 2.4g/Day MMX Mesalamine/Mesalazine Once Daily in Adult Subjects With Ulcerative Colitis


This study was designed to evaluate if subjects who achieve complete remission after 8 weeks
of acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD have better long-term
outcomes and remain in remission longer compared with subjects who demonstrate only partial
remission after acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD. Therefore,
subjects who achieve either complete or partial remission will enter into a 12-month
maintenance phase, during which they will receive MMX mesalamine/mesalazine 2.4g/day given
QD. Remission status for the 2 groups will be evaluated and compared at the end of this
12-month maintenance period. The data obtained from this study will provide scientifically
meaningful information to demonstrate that achieving complete remission (clinical and
endoscopic remission) is important for a better long-term prognosis, or that the current
paradigm of symptomatic treatment is appropriate.



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Setauket, New York 11733
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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2104 Harrisburg Pike
East Hempfield, Pennsylvania 17601
717-544-3404
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4800 Belfort Rd # 2
Jacksonville, Florida 32256
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612 Palmetto Street
New Smyrna Beach, Florida 32168
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Alexandria, Virginia 22304
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Anaheim, California 92801
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Annapolis, Maryland 21401
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Atlanta, Georgia 30342
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Beavercreek, Ohio 45440
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Bristol, Connecticut 06010
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Gainesville, Florida 32605
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Garden Grove, California 92840
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Great Neck, New York 11021
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Greensboro, North Carolina 27406
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Milwaukee, Wisconsin 53215
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Moline, Illinois 61265
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Palm Harbor, Florida 34684
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Pittsburg, Pennsylvania 15261
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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San Antonio, Texas 78229
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San Diego, California 92103
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Spartanburg, South Carolina 29303
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Troy, Michigan 48098
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