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drugset / Trial / NCT01210352

Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects

NCT01210352 ↗

Phase 3 Completed 61 enrolled Endo USA Inc., a Keenova Therapeutics Company
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2010-12-13
Primary completion
2017-10-06
Completion
2017-10-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxymorphone Small molecule 0.05 mg/kg Oral
Subject Oxymorphone Small molecule 0.1 mg/kg Oral
Subject Oxymorphone Small molecule 0.15 mg/kg Oral
Subject Oxymorphone Small molecule 0.2 mg/kg Oral

Indications

No indication recorded.