Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Asacol 400 mg; Asacol 400 mg
Intervention description: 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; 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
Intervention MeSH terms: Aminosalicylic Acid; Mesalamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 39.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.