Pain | Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids
Pain research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Oxycodone HCl controlled-release tabletsOxycodone HCl controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg - 240 mg daily) every 12 hours.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Oxycodone HCl controlled-releaseOxycodone hydrochloride (HCl) controlled-release (CR)
Start Date: November 2010
Completed Date: July 2014
Phase: Phase 3
Primary Outcome: The Number of Participants With Adverse Events as a Measure of Safety.
Secondary Outcome: Pain Right Now Assessment by Patients Aged 6 to < 12 Years
Study sponsors, principal investigator, and references
Lead Sponsor: Purdue Pharma LP