NCT01210352

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: All
• Age: 0 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post Operative Pain

Interventions

Type	Name	Description
DRUG	oxymorphone HCl	Comparison of different dosages of drug, 0.05mg/kg, 0.10mg/kg, 0.15mg/kg or 0.20mg/kg oral liquid oxymorphone

Timeline

• Start date: 2010-12-13
• Primary completion: 2017-10-06
• Completion: 2017-10-06
• First posted: 2010-09-28
• Last updated: 2021-08-20
• Results posted: 2019-05-07

Locations

8 sites across 1 country: United States