Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis

Condition(s) targeted: Ulcerative Colitis

Intervention: Asacol 400 mg (Drug); Asacol 400 mg (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Warner Chilcott

Official(s) and/or principal investigator(s):
Preston M Dunnmon, MD, Study Director, Affiliation: Procter and Gamble

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

The overall objective of this study is to assess the safety and efficacy of high dose and low dose Asacol administered as 400 mg delayed-release tablets given every 12 hours for 6 weeks to children and adolescents with mildly-to-moderately active ulcerative colitis.

Official title: Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8 g/Day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents With Mildly-to-Moderately Active Ulcerative Colitis

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

Primary outcome: Assessment of stool frequency and rectal bleeding

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

Criteria:

Inclusion Criteria:

- are male or female between the ages of 5 and 17 years, inclusive, at the time of the

first dose of study medication, with a history of biopsy and endoscopy confirmed UC;

- have mildly-to-moderately active UC (either newly diagnosed or that has relapsed) as

defined clinically by a Pediatric UC Activity Index (PUCAI) score 10 and 55, and, in the opinion of the Investigator, the patient does not require steroids;

- have baseline scores of at least 1 for both rectal bleeding (Streaks of blood with

stool less than half of the time) and stool frequency (1-2 stools greater than normal per day) as defined by the TM-Mayo Score

Exclusion Criteria:

- have UC known to be confined to the rectum (isolated rectal proctitis);

- 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

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

Research Facility, Birmingham, Alabama, United States; Recruiting

Research Facility, Phoenix, Arizona, United States; Recruiting

Research Facility, Loma Linda, California, United States; Recruiting

Research Facility, San Diego, California, United States; Recruiting

Research Facility, San Francisco, California, United States; Recruiting

Research Facility, Washington, District of Columbia, United States; Recruiting

Research Facility, Gainesville, Florida, United States; Recruiting

Research Facility, Park Ridge, Illinois, United States; Recruiting

Research Facility, Louisville, Kentucky, United States; Recruiting

Research Facility, Boston, Massachusetts, United States; Recruiting

Research Facility, Worcester, Massachusetts, United States; Recruiting

Research Facility, Kansas City, Missouri, United States; Recruiting

Research Facility, Omaha, Nebraska, United States; Recruiting

Research Facility, Mays Landing, New Jersey, United States; Recruiting

Research Facility, Buffalo, New York, United States; Recruiting

Research Facility, New Hyde Park, New York, United States; Recruiting

Research Facility, Halifax, Nova Scotia, Canada; Recruiting

Research Facility, Hamilton, Ohio, United States; Recruiting

Research Facility, Youngstown, Ohio, United States; Recruiting

Research Facility, Kingston, Ontario, Canada; Recruiting

Research Facility, Ottawa, Ontario, Canada; Recruiting

Research Facility, Portland, Oregon, United States; Recruiting

Research Facility, Montreal, Quebec, Canada; Recruiting

Research Facility, Chattanooga, Tennessee, United States; Recruiting

Research Facility, Knoxville, Tennessee, United States; Recruiting

Research Facility, Fort Worth, Texas, United States; Recruiting

Research Facility, Houston, Texas, United States; Recruiting

Research Facility, San Antonio, Texas, United States; Recruiting

Research Facility, Norfolk, Virginia, United States; Recruiting

Research Facility, Huntington, West Virginia, United States; Recruiting

Starting date: August 2008
Last updated: March 22, 2010