At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 86 enrolled
Drug / intervention
Tapentadoldrug
Likely dose
Tapentadol 1mg/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.
Open-label Evaluation of the Pharmacokinetic Profile, Safety, and Efficacy of Tapentadol Oral Solution for the Treatment of Post-surgical Pain in Children and Adolescents Aged From 2 Years to Less Than 18 Years.
In Brief
A Phase 2 clinical trial evaluating Tapentadol for Postoperative Pain and Acute Pain. Completed, enrolled 86 participants across 1 site.
Detailed Summary
To find out if a drug called tapentadol administered by mouth safely relieves pain in children. Look at the amount of tapentadol in the blood after a single oral dose. Tapentadol oral solution for children is still being tested and is not yet registered. Tapentadol tablets are effective in treating both acute and chronic pain in adults. This trial will help to understand how tapentadol oral solution works in children.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain, Acute Pain
CountriesUnited States
CollaboratorsJanssen Research & Development, LLC
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2012
First PostedNov 2012
Primary CompletionFeb 2014
TodayJul 2026
First PostedNov 20, 2012
Enrollment StartNov 1, 2012
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.6 years ago
Interventions
Tapentadoldrug
Tapentadol oral solution single dose (1mg/kg body weight)