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

Study Overview
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Brief Summary
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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.

Detailed Description
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An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.

Official Title
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An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.

Conditions
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Chronic Pain

Intervention / Treatment
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* Drug: Oxymorphone ER


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have 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 greater than or equal to 45 mg/daily (qd) oral morphine equivalent) Weigh at least 50 kg Expected to continue to require a strong opioid for pain relief for at least 4 weeks and up to 4 months. Exclusion Criteria: Have a life expectancy <4 weeks Plan to undergo a surgical procedure within 3 days of study entry or during the Titration Period Have dysphagia or difficulty swallowing whole tablets Have a previous exposure to oxymorphone Have an ileostomy

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxymorphone ER<br> | Drug: Oxymorphone ER<br>* 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<br>* Other names: Opana ER, Opana;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of Exposure to Oxymorphone Extended-Release: Average Daily Dose | Data based on drug accountability data from the case report forms. Data is based on the number of enrolled participants in each treatment period. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons. | Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of Exposure to Oxymorphone Extended-Release: Total Number of Tablets Taken | Data based on drug accountability data from the case report forms. Data is based on the number of enrolled participants in each treatment period. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons. | Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) | 
| Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Daily Dose | Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons. | Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) | 
| Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Average Number of Daily Rescues | Average number of daily rescues per day by participants. Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons. | Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) | 
| Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Number of Doses | Total number of doses (Tablets) taken by participants. Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons. | Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid tolerant, Pediatric, Male 6-17 years of age, Female 6-17 years of age, Pain, Non malignant, Malignant