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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Pain

Intervention / Treatment
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* Drug: oxymorphone IR


Participation Criteria
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Eligibility Criteria
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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 Parent/legal guardian is unable to effectively communicate the subject's status to the investigator

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: oxymorphone IR|oxymorphone IR liquid|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain intensity from baseline to last assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale. |  | weekly for 1 month during titration | 
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessment of Adverse Events, vital signs including oxygen saturation, Blood Pressure, and Heart Rate. |  | weekly for 1 month during titration | 
| Safety Assessment of Adverse Events, vital signs including oxygen saturation, Blood Pressure, and Heart Rate. |  | bi-weekly for 3 months in the maintenance phase | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sickle cell anemia, juvenile rheumatoid arthritis, burn victim, cancer, Chronic pain of malignant or non-malignant etiology