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 |
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.
We found this trial at
32
sites
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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
East Hempfield, Pennsylvania 17601
717-544-3404
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Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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