At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 61 enrolled
Drug / intervention
oxymorphone HCldrug
Likely dose
oxymorphone HCl 0.05mg/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.
An Open-Label, Non-randomized, Multicenter, Ascending Dose by Age, Single- and Multiple-Dose Evaluation of the Effectiveness, Safety, and Tolerability of Oral Liquid Oxymorphone HCl Immediate-Release Oral Liquid for Acute Postoperative Pain in Pediatric Subjects
In Brief
A Phase 3 clinical trial evaluating oxymorphone HCl for Post Operative Pain. Completed, enrolled 61 participants across 8 sites.
Detailed Summary
The purpose of this study is to evaluate the effectiveness, tolerability, and safety of oxymorphone immediate release (IR) oral liquid as an analgesic for acute postoperative pain in pediatric subjects. This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost Operative Pain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2010
Enrollment StartDec 2010
Primary CompletionOct 2017
TodayJul 2026
First PostedSep 28, 2010
Enrollment StartDec 13, 2010
Primary CompletionOct 6, 2017
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 15.8 years ago
Interventions
oxymorphone HCldrug
Comparison of different dosages of drug, 0.05mg/kg, 0.10mg/kg, 0.15mg/kg or 0.20mg/kg oral liquid oxymorphone