The purpose of this study is to determine whether low dose Asacol® (27 mg/kg - 71 mg/kg) and
high dose Asacol® (53 mg/kg - 118 mg/kg) are safe and effective when dosed as 400 mg
delayed-release tablets given twice daily for 26 weeks to children and adolescents for the
maintenance of remission of ulcerative colitis.
Minimum age: 5 Years.
Maximum age: 17 Years.
Gender(s): Both.
Inclusion Criteria:
- male or female between the ages of 5 and 17 years, inclusive, at the time of the
first dose of study medication;
- 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 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
- 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.
Research Site, Rijeka, Croatia
Research Site, Zagreb, Croatia
Research Site, Bialystok 15-274, Poland
Research Site, Bydgoszcz 85-094, Poland
Research Site, Katowice 40-752, Poland
Research Site, Krakow 30-663, Poland
Research Site, Lodz 91-738, Poland
Research Site, Warszawa 04-730, Poland
Research Site, Wroclaw 50-369, Poland
Research Site, Bucharest 00 17 43, Romania
Research Site, Bucharest 04 14 51, Romania
Research Site, Iasi 70 03 09, Romania
Research Site, Kazan 420138, Russian Federation
Research Site, Moscow 103001, Russian Federation
Research Site, Moscow 105077, Russian Federation
Research Site, Moscow 117963, Russian Federation
Research Site, Moscow 119021, Russian Federation
Research Site, Moscow 127412, Russian Federation
Research Site, N. Novgorod 603950, Russian Federation
Research Site, Novosibirsk 630091, Russian Federation
Research Site, Smolensk 214019, Russian Federation
Research Site, Birmingham, Alabama 35233, United States
Research Site, Edmonton, Alberta T6G 2J3, Canada
Research Site, Phoenix, Arizona 85016, United States
Research Site, Loma Linda, California 92354, United States
Research Site, San Diego, California 92123, United States
Research Site, San Francisco, California 94118, United States
Research Site, San Francisco, California 94143, United States
Research Site, Gainesville, Florida 32601, United States
Research Site, Miami, Florida 33155, United States
Research Site, Park Ridge, Illinois 60068, United States
Research Site, Louisville, Kentucky 40202, United States
Research Site, Portland, Maine 04102, United States
Research Site, Boston, Massachusetts 02114, United States
Research Site, Worcester, Massachusetts 01655, United States
Research Site, Southfield, Michigan 48075, United States
Research Site, Jackson, Mississippi 39202, United States
Research Site, Kansas City, Missouri 64108, United States
Research Site, Las Vegas, Nevada 89109, United States
Research Site, Mays Landing, New Jersey 08330, United States
Research Site, Buffalo, New York 14222, United States
Research Site, New Hyde Park, New York 11040, United States
Research Site, Halifax, Nova Scotia B3K 6R8, Canada
Research Site, Hamilton, Ontario L8N 3Z5, Canada
Research Site, London, Ontario N6A 5W9, Canada
Research Site, Ottawa, Ontario K1H 8L1, Canada
Research Site, Providence, Rhode Island 02903, United States
Research Site, Nashville, Tennessee 37232, United States
Research Site, Fort Worth, Texas 76104, United States
Research Site, San Antonio, Texas 78229, United States
Research Site, Huntington, West Virginia 25701, United States