Safety and Compliance of Taking Mesalamine Once a Day in Pediatric Patients

A Randomized Trial Comparing Once Daily Dosing vs. Multiple Doses a Day of Mesalamine in Pediatric Patients With Quiescent Ulcerative Colitis

To determine whether once a day administration of Mesalamine is at least as safe and efficacious and administration of multiple doses a day in preventing clinical relapse of ulcerative colitis in children and adolescence.

Is taking total dose in mg/kg once a day, as safe as taking total dose divided in mg/kg spreadout during the day in preventing clinical relapse of ulcerative colitis in children and adolescence.

Inclusion Criteria:

• Ages 6 to 18 years,
• Must be able to swallow tablets, and
• Biopsy proven ulcerative colitis

Exclusion Criteria:

• Allergy or hypersensitivity to Mesalamine or other salicylates
• Use of rectal medications