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

• Status: Terminated
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Annette Langseder
• Collaborator: Procter and Gamble
• Treatments: Mesalamine

Criteria

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