Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis
NCT ID: NCT01004185
Last Updated: 2012-05-25
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
39 participants
INTERVENTIONAL
2009-10-31
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
QUADRUPLE
Study Groups
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High Dose
2.0 - 4.8 g/day Asacol dependent on body weight
Asacol 400 mg
17-33kg = 3 Asacol 400mg AM \& 2 Asacol 400mg PM; 33-\<54kg = 5 Asacol 400 mg AM \& 4 Asacol 400mg PM; 54-\<90kg = 6 Asacol 400mg AM \& PM
Low Dose
1.2 - 2.4 g/day Asacol dependent upon body weight
Asacol 400 mg
17-\<33kg = 2 Asacol 400mg \& 1 placebo AM, 1 Asacol 400mg \& 1 placebo PM; 33-\<54kg = 3 Asacol 400mg \& 2 placebo AM, 2 Asacol 400mg \& 2 placebo PM; 54-\<90kg = 3 Asacol 400mg \& 3 placebo AM \& PM
Interventions
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Asacol 400 mg
17-33kg = 3 Asacol 400mg AM \& 2 Asacol 400mg PM; 33-\<54kg = 5 Asacol 400 mg AM \& 4 Asacol 400mg PM; 54-\<90kg = 6 Asacol 400mg AM \& PM
Asacol 400 mg
17-\<33kg = 2 Asacol 400mg \& 1 placebo AM, 1 Asacol 400mg \& 1 placebo PM; 33-\<54kg = 3 Asacol 400mg \& 2 placebo AM, 2 Asacol 400mg \& 2 placebo PM; 54-\<90kg = 3 Asacol 400mg \& 3 placebo AM \& PM
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* have a documented history of UC that has been successfully maintained in complete remission for at least 1 month prior to study entry
* have a baseline PUCAI score \< 10
* have a body weight no less than 17 kg and no more than 90 kg
* have a history of at least 1 active episode or relapse in the last 12 months
* have taken a stable maintenance dose of oral mesalamine (or equivalent oral 5-ASA dose) for at least 1 month prior to entry in the study. Stable is defined as the same dose for the last month.
* maintained complete remission, as defined, throughout the 30-day run-in phase. Note:ONLY applies to those patients who complete the 6-week treatment in complete remission from Study 2007017 and immediately roll-over to the 30-day run-in phase
* are female patients who are pre-menarchal or have a negative urine pregnancy test and, if sexually active, practice acceptable contraception (e.g., abstinence; oral, intramuscular, or implanted hormonal contraception \[at least 3 months prior to enrollment\]
Exclusion Criteria
* 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
* have a history or presence of any condition causing malabsorption or an effect on gastrointestinal motility or history of extensive small bowel resection (greater than one half the length of the small intestine) causing short bowel syndrome
* any "condition" causing "malabsorption" or an effect on gastrointestinal "motility"
* have current renal disease, or a screening blood urea nitrogen (BUN) or creatinine value that is \> 1.5 times the upper limit of the age appropriate normal
* have a documented history of or current hepatic disease, or liver function tests (alanine transaminase \[ALT\], aspartate transaminase \[AST\], total bilirubin) that are \> 2 times the upper limit of normal
* have a history of pancreatitis
* have undergone treatment with any oral, intravenous, intramuscular, or rectally administered corticosteroids (including budesonide) within 30 days prior to the Screening visit
* have undergone treatment with any rectal mesalamine therapy within 30 days prior to the screening visit
* have undergone treatment with immunomodulatory therapy including, but not limited to: rosiglitazone, 6-mercaptopurine or azathioprine, cyclosporine, or methotrexate within 90 days prior to Screening visit
* have undergone treatment with biologic therapy including, but not limited to: infliximab,adalimumab, certolizumab or other biologic treatment of ulcerative colitis within 90 days prior to Screening visit
* have undergone treatment with antibiotics (other than topical antibiotics) including metronidazole within 7 days prior to the Screening visit
* have undergone treatment with aspirin or other nonsteroidal anti-inflammatory drugs NSAIDs) within 7 days prior to the Screening visit
* have undergone treatment with any antidiarrheals and/or antispasmodics within 30 days of the Screening visit
* have a stool examination positive for Clostridium difficile (C. difficile), bacterial pathogens, or ova and parasites. Note: Because normal gut flora may vary by geography, the Medical Monitor should be consulted before excluding a patient with a stool sample that is positive for C. difficile, bacterial pathogens or ova and parasites.
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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Herman Ellman, MD
Role: STUDY_DIRECTOR
Warner Chilcott
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Loma Linda, California, United States
Research Site
San Diego, California, United States
Research Site
San Francisco, California, United States
Research Site
San Francisco, California, United States
Research Site
Gainesville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Park Ridge, Illinois, United States
Research Site
Louisville, Kentucky, United States
Research Site
Portland, Maine, United States
Research Site
Boston, Massachusetts, United States
Research Site
Worcester, Massachusetts, United States
Research Site
Southfield, Michigan, United States
Research Site
Jackson, Mississippi, United States
Research Site
Kansas City, Missouri, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Mays Landing, New Jersey, United States
Research Site
Buffalo, New York, United States
Research Site
New Hyde Park, New York, United States
Research Site
Providence, Rhode Island, United States
Research Site
Nashville, Tennessee, United States
Research Site
Fort Worth, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Huntington, West Virginia, United States
Research Site
Edmonton, Alberta, Canada
Research Site
Halifax, Nova Scotia, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
London, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Rijeka, , Croatia
Research Site
Zagreb, , Croatia
Research Site
Bialystok, , Poland
Research Site
Bydgoszcz, , Poland
Research Site
Katowice, , Poland
Research Site
Krakow, , Poland
Research Site
Lodz, , Poland
Research Site
Warsaw, , Poland
Research Site
Wroclaw, , Poland
Research Site
Bucharest, , Romania
Research Site
Bucharest, , Romania
Research Site
Iași, , Romania
Research Site
Kazan', , Russia
Research Site
Moscow, , Russia
Research Site
Moscow, , Russia
Research Site
Moscow, , Russia
Research Site
Moscow, , Russia
Research Site
Moscow, , Russia
Research Site
Nizhny Novgorod, , Russia
Research Site
Novosibirsk, , Russia
Research Site
Smolensk, , Russia
Countries
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Other Identifiers
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2008085
Identifier Type: -
Identifier Source: org_study_id
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