At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 50 enrolled
Drug / intervention
Morphine Sulfatedrug
Likely dose
Not stated in 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 Multicenter, Open Label, Safety and Pharmacokinetic Study of Oral Morphine Sulfate Administration in Pediatric Subjects 2 Years Old Through 17 Years Old With Postoperative Pain
In Brief
A Phase 4 clinical trial evaluating Morphine Sulfate for Pain. Completed, enrolled 50 participants across 11 sites.
Detailed Summary
The purpose of this study is to evaluate the tolerability and safety of oral morphine sulfate in the treatment of postoperative pain in different pediatric age groups following multiple-dose administration. To determine multiple-dose pharmacokinetics (PK) of morphine sulfate in pediatric subjects. To compare plasma concentration of morphine sulfate in each age group of pediatric subjects with adult plasma morphine sulfate concentrations.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2011
Enrollment StartApr 2011
Primary CompletionApr 2012
TodayJul 2026
First PostedMar 24, 2011
Enrollment StartApr 1, 2011
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 15.3 years ago
Interventions
Morphine Sulfatedrug