Clinical trial NCT01192295: Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids
Official title: An Open-label, Multicenter Study of the Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Opioid Experienced Children From Ages 6 to 16 Years Old, Inclusive, With Moderate to Severe Malignant and/or Nonmalignant Pain Requiring Opioid Analgesics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Malignant pain
Nonmalignant pain
Pediatric
Opioid
Moderate to severe malignant or nonmalignant pain
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2010-09-01
Enrollment: 155
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: The Number of Participants With Adverse Events as a Measure of Safety.
timeFrame: Up to 4 weeks (during the study) and 7-10 days poststudy (safety follow-up assessment).
Secondary outcomes:
measure: Pain Right Now Assessment by Patients Aged 6 to < 12 Years
timeFrame: Baseline to week 4
measure: Pain Right Now Assessment by Patients Aged ≥ 12 to ≤ 16 Years
timeFrame: Baseline to week 4
measure: Use of Supplemental Pain Medication
timeFrame: Baseline to week 4
measure: Parent/ Caregiver-Assessed Global Impression of Change (PGIC)
timeFrame: Baseline to week 4 or early discontinuation
measure: Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged 6 to < 12 Years
timeFrame: Baseline to week 4
measure: Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged ≥ 12 to ≤ 16 Years
timeFrame: Baseline to week 4
measure: Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets
timeFrame: Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose]
measure: Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - AUCtau and AUCss
timeFrame: Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose]
measure: Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - Time to Maximum Concentration (Tmax)
timeFrame: Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose]
measure: Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - Accumulation Ratio
timeFrame: Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose]
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's Hospital of Alabama
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama, Children's and Women's Hospital
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Palo Alto
country: United States
facility: LS Packard Children's Hospital
state: California
city: Paramount
country: United States
facility: Bayview Research Group, LLC
state: California
city: Sacramento
country: United States
facility: Shriners Hospitals for Children Northern California
state: California
city: Aurora
country: United States
facility: The Children's Hospital
state: Colorado
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Wilmington
country: United States
facility: Alfred I. duPont Hospital for Children
state: Delaware
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Miami
country: United States
facility: Jackson Memorial Hospital/University of Miami
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Grand Rapids
country: United States
facility: Helen DeVos Children's Hospital
state: Michigan
city: Saint Louis
country: United States
facility: St. John's Mercy Medical Center
state: Missouri
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Charlotte
country: United States
facility: Presbyterian Blume Pediatric Hematology and Oncology Clinic
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Department of Pediatrics, University of Oklahoma Health Sciences Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: The Children's Hospital at OUMC
state: Oklahoma
city: Portland
country: United States
facility: Legacy Emanuel Children's Hospital
state: Oregon
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Nashville
country: United States
facility: Monroe Carell Jr. Children's Hospital at Vanderbilt
state: Tennessee
city: Dallas
country: United States
facility: Children's Medical Ctr of Dallas
state: Texas
city: The Woodlands
country: United States
facility: Research Facility
state: Texas
city: Salt Lake City
country: United States
facility: Primary Children's Medical Center
state: Utah
city: Norfolk
country: United States
facility: Children's Hospital of the King's Daughters
state: Virginia
city: Richmond
country: United States
facility: Pediatric Hematology and Oncology, Virginia Commonwealth University Health System
state: Virginia
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
city: Athens
country: Greece
facility: Agia Sophia Children's Hospital
city: Athens
country: Greece
facility: Aglaia Kyriakou - Elpida Children's Oncology Unit
city: Budapest
country: Hungary
facility: Semmelweis Egyetem, II. sz. Gyermekgyogyaszati Klinika
city: Beersheba
country: Israel
facility: Soroka University Medical Center
city: Haifa
country: Israel
facility: Mayer Children Hospital, Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Ein Kerem
city: Petaẖ Tiqwa
country: Israel
facility: Schneider Children Medical Center of Israel
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Grafton
country: New Zealand
facility: Starship Children's Health
state: Auckland
city: Targu Mures
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Targu Mures, Clinica pediatrie I
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospital
Study officials:
References: