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

Phase 3CompletedNCT01192295

Purdue Pharma LP155 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

155

Conditions

Pain

Interventions

Oxycodone HCl controlled-release tabletsDRUG

Oxycodone HCl controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg - 240 mg daily) every 12 hours.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 16 Years

Medical Language ↔ Plain English

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.

Locations (47)

Outcomes

Primary Outcomes

The Number of Participants With Adverse Events as a Measure of Safety.

Safety assessments consisted of reports of AEs, physical examinations, clinical laboratory test results, vital signs measurements, pulse oximetry (SpO2), and somnolence assessments. Safety variables were summarized descriptively within age group for the safety population.

Time frame: Up to 4 weeks (during the study) and 7-10 days poststudy (safety follow-up assessment).

Secondary Outcomes

Pain Right Now Assessment by Patients Aged 6 to < 12 Years

Pain right now was assessed by patients aged 6 to \<12 years using the Faces of Pain Scale-Revised (FPS-R). The FPS-R is a horizontal row of 6 faces representing pain intensity, with "no hurt" at the far left and "hurts worst" at the far right; the 6 intensities are scored as 0, 2, 4, 6, 8, or 10 (the patient was not shown the numbers associated with the faces). A score of 0 means no pain, and a 10 means very much pain. Pain right now was assessed by the patient at screening; after the first dose; and, thereafter, twice daily during the AM and PM, approximately at the time of each (morning and evening) dose of oxycodone HCl CR tablets during the study treatment.

Time frame: Baseline to week 4

Pain Right Now Assessment by Patients Aged ≥ 12 to ≤ 16 Years

Pain right now was assessed by patients aged ≥ 12 to ≤ 16 years using the 100-mm visual analogue scale (VAS). The 100-mm VAS is a 100-mm line with 1 end marked "no pain" and the opposite end marked as "pain as bad as it could be." The patient was asked to make a mark on that line indicating his or her level of pain. The pain right now 100-mm VAS score was defined as the distance (in mm) from the "no pain" end to the patient's mark. The scale is measured on a 100 mm line: a 0 means no pain and bigger numbers indicate more pain. Pain right now was assessed by the patient at screening; after the first dose; and, thereafter, twice daily during the AM and PM, approximately at the time of each (morning and evening) dose of oxycodone HCl CR tablets during the study treatment.

Time frame: Baseline to week 4

Data from ClinicalTrials.gov

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Children's Hospital of Alabama

Birmingham, Alabama, United States

University of South Alabama, Children's and Women's Hospital

Mobile, Alabama, United States

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Loma Linda University Medical Center

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Children's Hospital Los Angeles

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LS Packard Children's Hospital

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Bayview Research Group, LLC

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The Children's Hospital

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...and 37 more locations