Trials / Completed
CompletedNCT01130844
Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis
A Phase 1, Multicenter, Open-label Study to Determine the Safety and Pharmacokinetics of MMX Mesalamine Following Administration in Children and Adolescents With Ulcerative Colitis
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 5 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the safety and pharmacokinetics of MMX mesalamine following administration in children and adolescents with ulcerative colitis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MMX Mesalamine | 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. |
| DRUG | MMX Mesalamine | 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. |
| DRUG | MMX Mesalamine | 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. |
Timeline
- Start date
- 2010-10-08
- Primary completion
- 2013-06-27
- Completion
- 2013-06-27
- First posted
- 2010-05-26
- Last updated
- 2021-06-14
- Results posted
- 2015-07-09
Locations
19 sites across 5 countries: United States, Australia, Poland, Slovakia, United Kingdom
Source: ClinicalTrials.gov record NCT01130844. Inclusion in this directory is not an endorsement.