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

Condition(s) targeted: Ulcerative Colitis

Intervention: Asacol (mesalamine), High Dose (Drug); Asacol (mesalamine), Low Dose (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Warner Chilcott

Overall contact:
Brian C Johnston, Phone: 513.622.5315, Email: johnston.bc@pg.com

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.

Official title: A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8g/Day) 400 mg Delayed-release Tablets Given Twice Daily for 26 Weeks to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis

Study design: Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: proportion of patients who have maintained complete remission through Week 26 as determined by a Pediatric Ulcerative Colitis Activity Index (PUCAI) score < 10 during the entire study period

Secondary outcome: proportion of patients who have maintained complete remission through Week 26 using an endpoint similar to the PUCAI (but with the PUCAI 3-level Abdominal Pain question replaced by a 5-level Abdominal Pain question)

Minimum age: 5 Years. Maximum age: 17 Years. Gender(s): Both.

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.

Brian C Johnston, Phone: 513.622.5315, Email: johnston.bc@pg.com

Research Site, Rijeka, Croatia; Not yet recruiting

Research Site, Zagreb, Croatia; Not yet recruiting

Research Site, Bialystok 15-274, Poland; Not yet recruiting

Research Site, Bydgoszcz 85-094, Poland; Not yet recruiting

Research Site, Katowice 40-752, Poland; Not yet recruiting

Research Site, Krakow 30-663, Poland; Not yet recruiting

Research Site, Lodz 91-738, Poland; Not yet recruiting

Research Site, Warszawa 04-730, Poland; Not yet recruiting

Research Site, Wroclaw 50-369, Poland; Not yet recruiting

Research Site, Bucharest 00 17 43, Romania; Not yet recruiting

Research Site, Bucharest 04 14 51, Romania; Not yet recruiting

Research Site, Iasi 70 03 09, Romania; Not yet recruiting

Research Site, Kazan 420138, Russian Federation; Not yet recruiting

Research Site, Moscow 117963, Russian Federation; Not yet recruiting

Research Site, Moscow 127412, Russian Federation; Not yet recruiting

Research Site, Moscow 119021, Russian Federation; Not yet recruiting

Research Site, Moscow 103001, Russian Federation; Not yet recruiting

Research Site, Moscow 105077, Russian Federation; Not yet recruiting

Research Site, N. Novgorod 603950, Russian Federation; Not yet recruiting

Research Site, Novosibirsk 630091, Russian Federation; Not yet recruiting

Research Site, Smolensk 214019, Russian Federation; Not yet recruiting

Research Site, Birmingham, Alabama 35233, United States; Not yet recruiting

Research Site, Edmonton, Alberta T6G 2J3, Canada; Not yet recruiting

Research Site, Phoenix, Arizona 85016, United States; Not yet recruiting

Research Site, Loma Linda, California 92354, United States; Not yet recruiting

Research Site, San Diego, California 92123, United States; Not yet recruiting

Research Site, San Francisco, California 94143, United States; Not yet recruiting

Research Site, San Francisco, California 94118, United States; Not yet recruiting

Research Site, Gainesville, Florida 32601, United States; Recruiting

Research Site, Miami, Florida 33155, United States; Not yet recruiting

Research Site, Park Ridge, Illinois 60068, United States; Recruiting

Research Site, Louisville, Kentucky 40202, United States; Not yet recruiting

Research Site, Portland, Maine 04102, United States; Not yet recruiting

Research Site, Boston, Massachusetts 02114, United States; Not yet recruiting

Research Site, Worcester, Massachusetts 01655, United States; Not yet recruiting

Research Site, Southfield, Michigan 48075, United States; Not yet recruiting

Research Site, Jackson, Mississippi 39202, United States; Not yet recruiting

Research Site, Kansas City, Missouri 64108, United States; Not yet recruiting

Research Site, Las Vegas, Nevada 89109, United States; Not yet recruiting

Research Site, Mays Landing, New Jersey 08330, United States; Recruiting

Research Site, Buffalo, New York 14222, United States; Not yet recruiting

Research Site, New Hyde Park, New York 11040, United States; Not yet recruiting

Research Site, Halifax, Nova Scotia B3K 6R8, Canada; Not yet recruiting

Research Site, Hamilton, Ontario L8N 3Z5, Canada; Not yet recruiting

Research Site, London, Ontario N6A 5W9, Canada; Not yet recruiting

Research Site, Ottawa, Ontario K1H 8L1, Canada; Not yet recruiting

Research Site, Providence, Rhode Island 02903, United States; Not yet recruiting

Research Site, Nashville, Tennessee 37232, United States; Not yet recruiting

Research Site, Fort Worth, Texas 76104, United States; Not yet recruiting

Research Site, San Antonio, Texas 78229, United States; Recruiting

Research Site, Huntington, West Virginia 25701, United States; Recruiting

Starting date: October 2009
Last updated: March 22, 2010