Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis
(CAMPIII Trial)
Recruiting in Palo Alto (17 mi)
+44 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Warner Chilcott
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Research Team
HE
Herman Ellman, MD
Principal Investigator
Warner Chilcott
Eligibility 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
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Treatment Details
Interventions
- Asacol 400 mg (Aminosalicylates)
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Low DoseExperimental Treatment1 Intervention
1.2 - 2.4 g/day Asacol dependent upon body weight
Group II: High DoseExperimental Treatment1 Intervention
2.0 - 4.8 g/day Asacol dependent on body weight
Find a Clinic Near You
Who Is Running the Clinical Trial?
Warner Chilcott
Lead Sponsor
Trials
61
Recruited
25,200+
Roger Boissonneault
Warner Chilcott
Chief Executive Officer since 2013
Bachelor's degree from Boston University, JD from Villanova University School of Law
Juan Sanchez
Warner Chilcott
Chief Medical Officer since 2014
MD from Pontifical Xavierian University