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Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects

NCT00765856 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2020-12-16

Study results available
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Summary

Patients will convert from current opioid to Oxymorphone ER and undergo titration. During the Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s) every 12 hours. Dosing adjustments will be based on the review of the subject's pain scores. Oxymorphone IR 5 mg will be provided to be used as supplemental "breakthrough" pain medication (as needed). Titration Period will end when the fixed dose of study medication is tolerated and the subject achieves adequate analgesia. Subjects will then proceed to the open-label 3-month maintenance period on the fixed dose of study medication established during the Titration Period.

Conditions

Interventions

DRUG

Oxymorphone ER

Oxymorphone ER dosing adjustments made under the direction of the Investigator during the Titration Period. Oxymorphone IR (Opana) IR 5mg tablet - used as rescue medications

Sponsors & Collaborators

  • Endo Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Sr. Director CR&D · Endo Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-11-17
Primary Completion
2010-02-22
Completion
2010-02-22

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 NCT00765856 on ClinicalTrials.gov