Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis
NCT ID: NCT00713310
Last Updated: 2012-04-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
83 participants
INTERVENTIONAL
2008-12-31
2011-03-31
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
TRIPLE
Study Groups
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Low-Dose
1.2 - 2.4 g/day Asacol dependent on body weight
Asacol 400 mg
Low dose:
17-\<33 kg = 2 Asacol 400mg + 1 placebo in morning and 1 Asacol 400 +1 placebo in PM, 33-\<54 kg = 3 Asacol 400mg +2 placebo in morning and 2 Asacol 400 + 2 placebo in PM, 54-\<90 kg = 3 Asacol 400mg + 3 placebo in morning and 3 Asacol 400mg + 3 placebo in PM
High-Dose
2.0 - 4.8 g/day Asacol dependent on body weight
Asacol 400 mg
High dose:
17-\<33 kg = 3 Asacol 400mg in morning and 2 Asacol 400 in PM, 33-\<54 kg = 5 Asacol 400mg in morning and 4 Asacol 400 in PM, 54-\<90 kg = 6 Asacol 400mg in morning and 6 Asacol 400 in PM
Interventions
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Asacol 400 mg
High dose:
17-\<33 kg = 3 Asacol 400mg in morning and 2 Asacol 400 in PM, 33-\<54 kg = 5 Asacol 400mg in morning and 4 Asacol 400 in PM, 54-\<90 kg = 6 Asacol 400mg in morning and 6 Asacol 400 in PM
Asacol 400 mg
Low dose:
17-\<33 kg = 2 Asacol 400mg + 1 placebo in morning and 1 Asacol 400 +1 placebo in PM, 33-\<54 kg = 3 Asacol 400mg +2 placebo in morning and 2 Asacol 400 + 2 placebo in PM, 54-\<90 kg = 3 Asacol 400mg + 3 placebo in morning and 3 Asacol 400mg + 3 placebo in PM
Eligibility Criteria
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Inclusion Criteria
* have mildly-to-moderately active UC (either newly diagnosed or that has relapsed) as defined clinically by a Pediatric UC Activity Index (PUCAI) score 10 and 55, and, in the opinion of the Investigator, the patient does not require steroids;
* have baseline scores of at least 1 for both rectal bleeding (Streaks of blood with stool less than half of the time) and stool frequency (1-2 stools greater than normal per day) as defined by the TM-Mayo Score
Exclusion Criteria
* have a history of allergy or hypersensitivity to salicylates, aminosalicylates, or any component of the Asacol tablet;
* have a significant co-existing illness or other condition(s), including but not limited to cancer or significant organic or psychiatric disease on medical history or physical examination, that, in the judgment of the Investigator, contraindicate(s) administration of the study drug and/or any study procedures
5 Years
17 Years
ALL
No
Sponsors
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Warner Chilcott
INDUSTRY
Responsible Party
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Principal Investigators
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Preston M Dunnmon, MD
Role: STUDY_DIRECTOR
Procter and Gamble
Locations
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Research Facility
Birmingham, Alabama, United States
Research Facility
Phoenix, Arizona, United States
Research Facility
Loma Linda, California, United States
Research Facility
San Diego, California, United States
Research Facility
San Francisco, California, United States
Research Facility
San Francisco, California, United States
Research Facility
Washington D.C., District of Columbia, United States
Research Facility
Gainesville, Florida, United States
Research Facility
Park Ridge, Illinois, United States
Research Facility
Louisville, Kentucky, United States
Research Facility
Boston, Massachusetts, United States
Research Facility
Worcester, Massachusetts, United States
Research Facility
Kansas City, Missouri, United States
Research Facility
Omaha, Nebraska, United States
Research Facility
Mays Landing, New Jersey, United States
Research Facility
Buffalo, New York, United States
Research Facility
New Hyde Park, New York, United States
Research Facility
Youngstown, Ohio, United States
Research Facility
Portland, Oregon, United States
Research Facility
Chattanooga, Tennessee, United States
Research Facility
Knoxville, Tennessee, United States
Research Facility
Fort Worth, Texas, United States
Research Facility
Houston, Texas, United States
Research Facility
San Antonio, Texas, United States
Research Facility
Norfolk, Virginia, United States
Research Facility
Huntington, West Virginia, United States
Research Facility
Halifax, Nova Scotia, Canada
Research Facility
Hamilton, Ontario, Canada
Research Facility
London, Ontario, Canada
Research Facility
Ottawa, Ontario, Canada
Research Facility
Montreal, Quebec, Canada
Research Site
Rijeka, Croatia, Croatia
Research Site
Zagreb, Croatia, Croatia
Research Site
Bialystok, Poland, Poland
Research Site
Bydgoszcz, Poland, Poland
Research Site
Krakow, Poland, Poland
Research Site
Lodz, Poland, Poland
Research Site
Warsazawa, Poland, Poland
Research Site
Wroclaw, Poland, Poland
Research Site
Bucharest, Romania, Romania
Research Site
Bucharest, Romania, Romania
Research Site
Iași, Romania, Romania
Countries
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References
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Winter HS, Krzeski P, Heyman MB, Ibarguen-Secchia E, Iwanczak B, Kaczmarski M, Kierkus J, Kolacek S, Osuntokun B, Quiros JA, Shah M, Yacyshyn B, Dunnmon PM. High- and low-dose oral delayed-release mesalamine in children with mild-to-moderately active ulcerative colitis. J Pediatr Gastroenterol Nutr. 2014 Dec;59(6):767-72. doi: 10.1097/MPG.0000000000000530.
Other Identifiers
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2007017
Identifier Type: -
Identifier Source: org_study_id
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