drugset / Trial / NCT00254618
A Study of Asacol Absorption, Metabolism and Excretion in Children and Adolescents With Ulcerative Colitis.
RandomizedParallel-groupOpen-label
Summary
The purpose of this randomized, open-label, parallel-group study is to determine how the body absorbs and eliminates mesalamine following administration of either 30 mg/kg/day, 60 mg/kg/day or 90 mg/kg/day as 400 mg delayed-release tablets given every 12 hours of 28 days to children and adolescents with active ulcerative colitis.
Timeline
- Start
- 2005-10
- Primary completion
- 2008-06
- Completion
- 2008-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mesalamine | Small molecule | 30 mg/kg | Oral |
| Subject | Mesalamine | Small molecule | 60 mg/kg | Oral |
| Subject | Mesalamine | Small molecule | 90 mg/kg | Oral |