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

NCT04681027 · Status: SUSPENDED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-12-23

No results posted yet for this study

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

Interventions

DRUG

Oxymorphone hydrochloride (HCl)

Opioid

Sponsors & Collaborators

  • Endo Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Saji Vijayan · Endo Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-11
Primary Completion
2017-04-04
Completion
2021-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04681027 on ClinicalTrials.gov