Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids



Trial Phase

Phase 3

Trial Purpose and Description

Trial Purpose

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.

Participation Guidelines

6 Years - 16 Years

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

- 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.
Purdue Pharma LP
November 2010
Last Updated:
May 27, 2014
Study HIC#:
1107008863 ID: NCT01192295