Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001

Study Overview
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Brief Summary
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The purpose of this study is to characterize the long-term safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid experienced pediatric patients aged 6 to 17 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy who completed the 4 -week treatment period in OTR3001.

Official Title
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An Open-label, Extension Study to Assess the Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Opioid Experienced Children Who Completed the OTR3001 Study

Conditions
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Pain

Intervention / Treatment
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* Drug: Oxycodone hydrochloride controlled-release tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria include: Male and female patients aged 6 to 17 years, inclusive, who completed the 4-week study drug treatment in study OTR3001 and who, based on the investigator's judgment, will benefit from continuing treatment with oxycodone HCl CR 20 to 240 mg/day for the management of moderate to severe malignant or nonmalignant pain; Patients must have tolerated the oxycodone HCl CR therapy in OTR3001 as demonstrated at the start of the study; Patients must be willing and able to swallow the oxycodone HCl CR tablets whole. Exclusion Criteria include: Patients with ongoing adverse events in OTR3001 that, in the investigator's opinion, disqualify them from participation in the study; Female patients who are pregnant or lactating; Patients requiring opioid at doses equivalent to < 20 mg/day or > 240 mg/day oxycodone for treatment of their malignant or nonmalignant pain; Patients who are allergic to oxycodone or have a history of allergies to other opioids (this criterion does not include patients who have experienced common opioid side effects [eg, nausea, constipation]); Patients who are contraindicated for the use of opioids; Patients who are currently being maintained on methadone for pain; Patients who have an abnormality on vital signs, physical examination, or laboratory testing significant enough that the investigator deems the patient is not appropriate for the study; Patients who have any planned surgery during the course of the study, with the exception of the placement of central or peripheral venous access devices; Patients currently taking an investigational medication/therapy other than the study drug (oxycodone HCl CR) at the start of screening or during the study. Other protocol specific inclusion/exclusion criteria may apply.

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: Oxycodone HCl controlled-release<br>Oxycodone hydrochloride controlled-release tablets | Drug: Oxycodone hydrochloride controlled-release tablets<br>* Oxycodone hydrochloride controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg to 240 mg daily) every 12 hours.<br>* Other names: OxyContin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants With Adverse Events as a Measure of Safety. | Safety assessments included adverse events (AEs), vital sign measurements, clinical laboratory test results, and somnolence (University of Michigan Sedation Scale [UMSS]). Safety variables were summarized descriptively within age group for the extension safety population. | Up to 6 months (during the study) and 7-10 days poststudy (safety follow-up assessment). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malignant pain, Nonmalignant pain, Pain, Pediatric, Opioid, Moderate to severe