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

Completed · Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT00713310

Run by

Warner Chilcott

People needed

83

Starts

2008-12-01

Expected to finish

2011-03-01

Last updated by the study team

2012-04-05

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Facility — Birmingham, Alabama, United States
• Research Facility — Phoenix, Arizona, United States
• Research Facility — Loma Linda, California, United States
• Research Facility — San Diego, California, United States
• Research Facility — San Francisco, California, United States
• Research Facility — San Francisco, California, United States
• Research Facility — Washington D.C., District of Columbia, United States
• Research Facility — Gainesville, Florida, United States
• Research Facility — Park Ridge, Illinois, United States
• Research Facility — Louisville, Kentucky, United States
• Research Facility — Boston, Massachusetts, United States
• Research Facility — Worcester, Massachusetts, United States
• Research Facility — Kansas City, Missouri, United States
• Research Facility — Omaha, Nebraska, United States
• Research Facility — Mays Landing, New Jersey, United States
• Research Facility — Buffalo, New York, United States
• Research Facility — New Hyde Park, New York, United States
• Research Facility — Youngstown, Ohio, United States
• Research Facility — Portland, Oregon, United States
• Research Facility — Chattanooga, Tennessee, United States
• Research Facility — Knoxville, Tennessee, United States
• Research Facility — Fort Worth, Texas, United States
• Research Facility — Houston, Texas, United States
• Research Facility — San Antonio, Texas, United States
• Research Facility — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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