Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids
Condition: Pain
Intervention: Oxycodone HCl controlled-release tablets
Intervention description: Oxycodone HCl controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg - 240 mg daily) every 12 hours.
Intervention MeSH terms: Oxycodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 155.0
Sex: All
Minimum age: 6 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Malignant pain; Nonmalignant pain; Pediatric; Opioid; Moderate to severe malignant or nonmalignant pain

Summary:

      The purpose of this study is to characterize the safety of oxycodone hydrochloride (HCl)
      controlled-release (CR) tablets in opioid tolerant pediatric patients aged 6 to 16 years,
      inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid
      therapy.
    

Eligibility criteria:

        Inclusion Criteria include:

          -  Male and female patients aged 6 to 16 years, inclusive, who are expected to require
             ongoing around-the-clock opioid treatment equivalent to at least 20-mg daily dose of
             oxycodone for at least 2 weeks for management of moderate to severe (based on the
             investigator's judgment) malignant or nonmalignant pain.

          -  Patients must be opioid tolerant, ie, have been treated with opioids for at least the
             5 consecutive days prior to dosing and with at least 20 mg daily of oxycodone or the
             equivalent during at least the last 48 hours prior to the start of study drug dosing
             and have tolerated the therapy, as demonstrated at the start of study drug dosing.

          -  Patients who are currently using transdermal fentanyl should have been on the patch
             for at least 3 days before removing the patch and oxycodone hydrochloride (HCl)
             controlled-release (CR) treatment can only be initiated at least 18 hours following
             the removal of the transdermal fentanyl patch.

          -  Patients must not require more than a 240-mg total daily dose of oxycodone HCl CR
             tablets.

          -  Patients must be willing and able to swallow the oxycodone HCl CR tablets whole.

          -  Patients must not be currently on an investigational medication/therapy at the start
             of screening or during the study.

        Exclusion Criteria include:

          -  Female patients who are pregnant or lactating.

          -  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 have received epidural opioids < 2 hours prior to the first dose of study
             drug or who have received epidural morphine < 12 hours prior to the first dose of
             study drug.

          -  Patients who are contraindicated for the use of opioids.

          -  Patients who are contraindicated for blood sampling.

          -  Patients who are currently being maintained on methadone for pain.

          -  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 who have had surgery within 5 days prior to Day 1 (day of first dose of study
             drug).

          -  Patients who, in the investigator's opinion, have an underlying gastrointestinal
             condition or other disorder that may predispose them to obstruction.

        Other protocol-specific inclusion/exclusion criteria may apply.