AN OPEN-LABEL, NON-RANDOMIZED, MULTICENTER EFFECTIVENESS, SAFETY AND TOLERABILITY STUDY OF OXYMORPHONE HCl IMMEDIATE-RELEASE ORAL LIQUID IN OPIOID-TOLERANT PEDIATRIC SUBJECTS WITH CHRONIC PAIN REQUIRING AN AROUND THE CLOCK OPIOID

Endo Pharmaceuticals0 sitesOctober 2010

ConditionsChronic Pain

Drugsoxymorphone IR

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Chronic Pain
Sponsor: Endo Pharmaceuticals
Primary Endpoint: Change in pain intensity from baseline to last assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale.
Status: Withdrawn
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the effectiveness, tolerability, and safety of oxymorphone immediate release (IR) oral liquid as an analgesic in pediatric subjects having severe to moderate chronic pain.

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

December 2013

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Endo Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

•Males or females 2 to ≤6 years of age, inclusive
•Chronic cancer or non-cancer pain, currently requiring treatment of pain with a strong opioid for at least 5 days (3 of 5 days at a dose \>1 mg/kg qd oral morphine equivalent)
•Expected to continue to require a strong opioid for pain relief for at least 4 months
•Able to swallow the oxymorphone HCl immediate-release oral liquid
•Have been informed of the nature of the study and informed consent and assent by minor (if IRB required) has been obtained from the legally responsible parent/legal guardian in accordance with IRB requirements

Exclusion Criteria

•Known allergy to, or a significant reaction to, oxymorphone or another opioid
•Life expectancy \<4 months
•Any clinical condition in the investigator's opinion that would preclude participation
•Plan to undergo a surgical procedure within 1 month of study entry or anytime during study
•Currently prescribed a long-acting opioid (eg., Kadian® morphine sulfate extended release) as part of their analgesic regimen
•Received any investigational medication within 30 days prior to the first dose of study medication, or are scheduled to receive an investigational drug other than oxymorphone during the course of the study
•An ileostomy
•Received a monoamine oxidase inhibitor (MAOI) within 14 days prior to the start of study medication
•Investigator anticipates that the subject would be unable to comply with the protocol
•Parent/legal guardian is unable to complete the subject's daily study medication diary

Outcomes

Primary Outcomes

Change in pain intensity from baseline to last assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale.

Time Frame: bi-weekly for three months in the maintenance phase

Secondary Outcomes

Safety Assessment of Adverse Events, vital signs including oxygen saturation, Blood Pressure, and Heart Rate.(bi-weekly for 3 months in the maintenance phase)