drugset / Trial / NCT04681027

Safety, Tolerability, Effectiveness, and Pharmacokinetic Data in Opioid-experienced Children

NCT04681027

Phase 3 Suspended 15 enrolled Endo USA Inc., a Keenova Therapeutics Company
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study was to assess the safety and pharmacokinetics (single- and multiple-dose) of oxymorphone ER for the relief of moderate to severe pain in pediatric participants ages 7 - ≤17 years old requiring a continuous, around-the-clock (ATC) opioid treatment for an extended period.

Timeline

Start
2013-03-11
Primary completion
2017-04-04
Completion
2021-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Oxymorphone Small molecule

Indications