Safety and Compliance of Taking Mesalamine Once a Day in Pediatric Patients
| Status: | Terminated |
|---|---|
| Conditions: | Colitis, Colitis, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 6 - 18 |
| Updated: | 1/31/2019 |
| Start Date: | July 2006 |
| End Date: | January 2011 |
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.
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.
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
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