Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Opioid Tolerant Pediatric Subjects

Phase 3

Withdrawn

• Conditions: Chronic Pain

• Registration Number: NCT01206907
• Lead Sponsor: Endo Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-17
• Study First Submitted QC: 2010-09-21
• Study First Posted: 2010-09-22
• Study Start: 2010-10
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-15
• Last Update Posted: 2012-08-17
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Males or females 2 to ≤6 years of age, inclusive
2. 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)
3. Expected to continue to require a strong opioid for pain relief for at least 4 months
4. Able to swallow the oxymorphone HCl immediate-release oral liquid
5. 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

1. Known allergy to, or a significant reaction to, oxymorphone or another opioid
2. Life expectancy <4 months
3. Any clinical condition in the investigator's opinion that would preclude participation
4. Plan to undergo a surgical procedure within 1 month of study entry or anytime during study
5. Currently prescribed a long-acting opioid (eg., Kadian® morphine sulfate extended release) as part of their analgesic regimen
6. 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
7. An ileostomy
8. Received a monoamine oxidase inhibitor (MAOI) within 14 days prior to the start of study medication
9. Investigator anticipates that the subject would be unable to comply with the protocol
10. Parent/legal guardian is unable to complete the subject's daily study medication diary
11. Parent/legal guardian is unable to effectively communicate the subject's status to the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in pain intensity from baseline to last assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale.	bi-weekly for three months in the maintenance phase

Secondary Outcome Measures

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