Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)
NCT ID: NCT00577473
Last Updated: 2011-09-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
301 participants
INTERVENTIONAL
2001-02-28
2003-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
mesalamine 2.4 g/day (400 mg tablet) for 6 weeks
mesalamine
mesalamine 2.4 g/day (400 mg tablet) for 6 weeks
2
mesalamine 4.8 g/day (800 mg tablet) for 6 weeks
mesalamine
mesalamine 4.8 g/day (800 mg tablet) for 6 weeks
Interventions
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mesalamine
mesalamine 2.4 g/day (400 mg tablet) for 6 weeks
mesalamine
mesalamine 4.8 g/day (800 mg tablet) for 6 weeks
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* a history of extensive small bowel resection
18 Years
65 Years
ALL
No
Sponsors
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Warner Chilcott
INDUSTRY
Responsible Party
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Principal Investigators
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Jeffery Kralstein, MD
Role: STUDY_DIRECTOR
Procter and Gamble
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Anaheim, California, United States
Research Site
Sacramento, California, United States
Research Site
San Francisco, California, United States
Research Site
Denver, Colorado, United States
Research Facility
Golden, Colorado, United States
Research Site
Bridgeport, Connecticut, United States
Research Site
Fort Myers, Florida, United States
Research Site
Hollywood, Florida, United States
Research Site
Jupiter, Florida, United States
Research Site
Miami, Florida, United States
Research Facility
Atlanta, Georgia, United States
Research Facility
Decatur, Georgia, United States
Research Site
Arlington Heights, Illinois, United States
Research Site
Moline, Illinois, United States
Research Site
Rockford, Illinois, United States
Research Site
Wichita, Kansas, United States
Research Site
Metairie, Louisiana, United States
Research Site
Baltimore, Maryland, United States
Research Site
Laurel, Maryland, United States
Research Site
Detroit, Michigan, United States
Research Site
New Brunswick, New Jersey, United States
Research Site
Somerville, New Jersey, United States
Research Site
Great Neck, New York, United States
Research Site
Pomona, New York, United States
Research Facility
Poughkeepsie, New York, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Tulsa, Oklahoma, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Charleston, South Carolina, United States
Research Facility
Memphis, Tennessee, United States
Research Facility
Nashville, Tennessee, United States
Research Site
Fort Worth, Texas, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Burlington, Vermont, United States
Research Site
Charlottesville, Virginia, United States
Research Facility
Falls Church, Virginia, United States
Research Site
Norfolk, Virginia, United States
Research Site
Tacoma, Washington, United States
Research Site
Milwaukee, Wisconsin, United States
Countries
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References
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Orchard TR, van der Geest SA, Travis SP. Randomised clinical trial: early assessment after 2 weeks of high-dose mesalazine for moderately active ulcerative colitis - new light on a familiar question. Aliment Pharmacol Ther. 2011 May;33(9):1028-35. doi: 10.1111/j.1365-2036.2011.04620.x. Epub 2011 Mar 8.
Lichtenstein GR, Ramsey D, Rubin DT. Randomised clinical trial: delayed-release oral mesalazine 4.8 g/day vs. 2.4 g/day in endoscopic mucosal healing--ASCEND I and II combined analysis. Aliment Pharmacol Ther. 2011 Mar;33(6):672-8. doi: 10.1111/j.1365-2036.2010.04575.x. Epub 2011 Jan 23.
Other Identifiers
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2000083
Identifier Type: -
Identifier Source: org_study_id
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