Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis
NCT ID: NCT00073021
Last Updated: 2015-06-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
386 participants
INTERVENTIONAL
2000-09-30
2003-09-30
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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Asacol 2.4 g/day
Asacol (2.4 g/day)
Asacol 400 mg (mesalamine)
tablets, 2.4 g/day for 6 weeks, 2 - 400 mg Asacol tablets and 2 placebo tablets 3 times daily
Asacol 4.8 g/day
Asacol (4.8 g/day)
Asacol 800 mg (mesalamine)
tablets, 4.8 g/day for 6 weeks, 2 - 800 mg Asacol tablets and 2 placebo tablets 3 times daily
Interventions
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Asacol 800 mg (mesalamine)
tablets, 4.8 g/day for 6 weeks, 2 - 800 mg Asacol tablets and 2 placebo tablets 3 times daily
Asacol 400 mg (mesalamine)
tablets, 2.4 g/day for 6 weeks, 2 - 400 mg Asacol tablets and 2 placebo tablets 3 times daily
Eligibility Criteria
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Inclusion Criteria
* have a confirmed diagnosis of ulcerative colitis with the extent varying from proctitis to pancolitis;
* currently demonstrating moderately active disease
Exclusion Criteria
* a history of allergy or hypersensitivity to salicylates or aminosalicylates;
* a history of extensive small bowel resection (\>1/2 the length of the small intestine) causing short bowel syndrome;
* current renal or hepatic disease;
* participated in any drug or device clinical study within 30 days of entry;
* currently enrolled in any other clinical study;
* received any oral, intravenous, intramuscular, or rectally administered corticosteroids within 1 month prior to the Baseline Visit;
* received any other topical rectal therapy during the week prior to the Screening Visit;
* received immunomodulatory therapy including, but not limited to, 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate within 3 months prior to the Baseline Visit;
* received a dose of mesalamine-containing compound by any route from which more than 1.6 g/day of mesalamine was available within 1 week prior to the Screening Visit (NOTE: 4 g/day of sulfasalazine and 4.5 g/day of balsalazide are equivalent to 1.6 g/day of mesalamine);
* received antibiotics, other than topical antibiotics, within 1 week prior to the Screening Visit;
* received aspirin (except for cardioprotective reasons up to a maximum dose of 325 mg/day) or NSAIDs within 1 week prior to the Baseline Visit;
* if female, positive pregnancy test, or lactating.
18 Years
75 Years
ALL
No
Sponsors
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Warner Chilcott
INDUSTRY
Responsible Party
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Principal Investigators
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Piotr Krzeski, MD
Role: STUDY_DIRECTOR
Procter and Gamble
Locations
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Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
AGMG Clinical Research
Anaheim, California, United States
Research Site
Los Angeles, California, United States
Community Clinical Trials
Orange, California, United States
AGMG Clinical Research
Orange, California, United States
Research Site
Sacramento, California, United States
Sharp Rees-Stealy Medical Group
San Diego, California, United States
Research Site
Arvada, Colorado, United States
Research Site
Englewood, Colorado, United States
Center for Medical Research, LLC
Manchester, Connecticut, United States
Center for GI Disorders
Hollywood, Florida, United States
Research Site
Maitland, Florida, United States
Advanced Gastroenterology Associates
Palm Harbor, Florida, United States
Research Site
Zephyrhills, Florida, United States
Southeast Research Associates
Marietta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
GI Research
Metairie, Louisiana, United States
Louisiana Research Center
Shreveport, Louisiana, United States
Digestive Disorders Associates
Annapolis, Maryland, United States
Research Site
Baltimore, Maryland, United States
Digestive Disease Associates
Baltimore, Maryland, United States
Metropolitan Gastroenterology Group
Chevy Chase, Maryland, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
PharmaTrials, Inc.
Hillsborough, New Jersey, United States
Research Site
Forest Hills, New York, United States
Long Island Clinical Research Associates
Great Neck, New York, United States
Research Site
New York, New York, United States
Carolinas Digestive Health Associates
Charlotte, North Carolina, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Statesville, North Carolina, United States
Consultants for Clinical Research
Cincinnati, Ohio, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Columbus, Ohio, United States
GI & Liver Consultants
Dayton, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Tulsa, Oklahoma, United States
West Hills Gastroenterology Group
Portland, Oregon, United States
Research Site
Altoona, Pennsylvania, United States
Research Site
Hanover, Pennsylvania, United States
Regional Research Institute
Jackson, Tennessee, United States
Research Site
Austin, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Houston, Texas, United States
Houston Medical Research Associates
Houston, Texas, United States
Research Site
Temple, Texas, United States
Research Site
Ogden, Utah, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
Research Site
Fairfax, Virginia, United States
Research Site
Fredericksburg, Virginia, United States
Richmond GI Research
Richmond, Virginia, United States
Research Site
Spokane, Washington, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States
Research Site
Richmond, British Columbia, Canada
Research Site
Toronto, Ontario, Canada
University of Puerto Rico, School of Medicine
San Juan, , Puerto Rico
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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2000082
Identifier Type: -
Identifier Source: org_study_id
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