NCT04681027

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

A Multicenter Study of the Safety, Tolerability, Effectiveness, and Pharmacokinetics of Oxymorphone HCL Extended-Release Tablets in Pediatric Subjects Requiring an Around-The-Clock Opioid for an Extended Period of Time

• Status: Suspended
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Pain
• Postsurgical Pain

Interventions

Type	Name	Description
DRUG	Oxymorphone hydrochloride (HCl)	Opioid

Timeline

• Start date: 2013-03-11
• Primary completion: 2017-04-04
• Completion: 2021-01-01
• First posted: 2020-12-23
• Last updated: 2020-12-23

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study