Overview

Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis

Status:
Terminated
Trial end date:
2011-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Warner Chilcott
Treatments:
Aminosalicylic Acid
Mesalamine
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.