At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 73 enrolled
Drug / intervention
Tapentadol prolonged release +1 moredrug
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.
An Open-label Trial, Enrolling Subjects Aged 6 Years to Less Than 18 Years Suffering From Pain Requiring Prolonged Release Opioid Treatment, to Evaluate the Safety and Efficacy of Tapentadol PR Versus Morphine PR, Followed by an Open-label Extension
In Brief
A Phase 3 clinical trial evaluating Tapentadol prolonged release and Morphine prolonged release for Pain. Completed, enrolled 73 participants across 23 sites in 10 countries.
Detailed Summary
Tapentadol has already been studied in adults. This study is needed to find out if tapentadol works and is safe to use in children and adolescents with long-term pain.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesBelgium, Bulgaria, Chile, France, Germany, Hungary, Italy, Portugal, Spain, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 2014
Enrollment StartApr 2015
Primary CompletionOct 2017
Study CompletionOct 2018
TodayJul 2026
First PostedMay 30, 2014
Enrollment StartApr 29, 2015
Primary CompletionOct 18, 2017
Study CompletionOct 15, 2018
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 12.1 years ago
Interventions
Tapentadol prolonged releasedrug
Morphine prolonged releasedrug