At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 52 enrolled
Drug / intervention
MMX Mesalamine +2 moredrug
Likely dose
MMX Mesalamine 30 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating MMX Mesalamine for Ulcerative Colitis. Completed, enrolled 52 participants across 19 sites in 5 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesAustralia, Poland, Slovakia, United Kingdom, United States
Collaborators--
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2010
Enrollment StartOct 2010
Primary CompletionJun 2013
TodayJul 2026
First PostedMay 26, 2010
Enrollment StartOct 8, 2010
Primary CompletionJun 27, 2013
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 16.1 years ago
Interventions
MMX Mesalaminedrug
30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX Mesalaminedrug
60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX Mesalaminedrug
100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.