NCT01004185

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Asacol 400 mg	17-33kg = 3 Asacol 400mg AM \& 2 Asacol 400mg PM; 33-\<54kg = 5 Asacol 400 mg AM \& 4 Asacol 400mg PM; 54-\<90kg = 6 Asacol 400mg AM \& PM
DRUG	Asacol 400 mg	17-\<33kg = 2 Asacol 400mg \& 1 placebo AM, 1 Asacol 400mg \& 1 placebo PM; 33-\<54kg = 3 Asacol 400mg \& 2 placebo AM, 2 Asacol 400mg \& 2 placebo PM; 54-\<90kg = 3 Asacol 400mg \& 3 placebo AM \& PM

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2009-10-29
• Last updated: 2012-05-25
• Results posted: 2012-05-25

Locations

51 sites across 6 countries: United States, Canada, Croatia, Poland, Romania, Russia