Status:
COMPLETED
Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis
Lead Sponsor:
Warner Chilcott
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
5-17 years
Phase:
PHASE3
Brief Summary
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 an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00713310
Start Date
December 1 2008
End Date
March 1 2011
Last Update
April 5 2012
Active Locations (42)
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1
Research Facility
Birmingham, Alabama, United States, 35233
2
Research Facility
Phoenix, Arizona, United States, 85016
3
Research Facility
Loma Linda, California, United States, 92354
4
Research Facility
San Diego, California, United States, 92123