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

NCT02687451 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2021-10-26

Study results available
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Summary

The purpose of the study is to evaluate the efficacy, tolerability, safety and pharmacokinetics of Oxymorphone HCl as an analgesic for acute moderate to severe post-operative pain in pediatric subjects.

Conditions

  • Post-Operative Pain
  • Acute Pain

Interventions

DRUG

Oxymorphone HCl

Oral liquid and injection; dose to be determined by Independent Data Monitoring Committee (IDMC).

DRUG

Placebo

Placebo Comparator for the double-blinded, placebo-controlled multiple-dose phase.

Sponsors & Collaborators

  • Endo Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Shannon Dalton · Endo Pharmceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2020-07-01
Completion
2020-09-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02687451 on ClinicalTrials.gov