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

NCT01192295 | Completed Phase 3 Results DMC

• 2 other identifiers: OTR30012010-020471-23
• Study Type: interventional
• Target: 155
• Locations: 8 countries
• Sites: 47

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.

Conditions

Pain

Keywords

Malignant pain; Nonmalignant pain; Pediatric; Opioid; Moderate to severe malignant or nonmalignant pain

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (10)

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

  Baseline to week 4

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

  Baseline to week 4

• Use of Supplemental Pain Medication

  Baseline to week 4

• Parent/ Caregiver-Assessed Global Impression of Change (PGIC)

  Baseline to week 4 or early discontinuation

• Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged 6 to < 12 Years

  Baseline to week 4

Study Arms (1)

Oxycodone HCl controlled-release

EXPERIMENTAL

Oxycodone hydrochloride (HCl) controlled-release (CR)

Drug: Oxycodone HCl controlled-release tablets

Interventions

Oxycodone HCl controlled-release tablets DRUG

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

Also known as: OxyContin

Oxycodone HCl controlled-release

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Purdue Pharma LP: lead

Study Sites (47)

Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

Location

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

Mobile, Alabama, 36604, United States

Location

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

LS Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

Bayview Research Group, LLC

Paramount, California, 90723, United States

Location

Shriners Hospitals for Children Northern California

Sacramento, California, 95817, United States

Location

The Children's Hospital

Aurora, Colorado, 80045, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Alfred I. duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Memorial Regional Hospital

Hollywood, Florida, 33021, United States

Location

Jackson Memorial Hospital/University of Miami

Miami, Florida, 33136, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Children's Memorial Hospital

Chicago, Illinois, 60614, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Helen DeVos Children's Hospital

Grand Rapids, Michigan, 49503, United States

Location

St. John's Mercy Medical Center

St Louis, Missouri, 63141, United States

Location

New York University Langone Medical Center

New York, New York, 10016, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

Presbyterian Blume Pediatric Hematology and Oncology Clinic

Charlotte, North Carolina, 28204, United States

Location

Duke University Medical Center

Durham, North Carolina, 22710, United States

Location

Akron Children's Hospital

Akron, Ohio, 44308, United States

Location

Department of Pediatrics, University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

The Children's Hospital at OUMC

Oklahoma City, Oklahoma, 73104, United States

Location

Legacy Emanuel Children's Hospital

Portland, Oregon, 97227, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

Location

Children's Medical Ctr of Dallas

Dallas, Texas, 75235, United States

Location

Research Facility

The Woodlands, Texas, 77381, United States

Location

Primary Children's Medical Center

Salt Lake City, Utah, 84113, United States

Location

Children's Hospital of the King's Daughters

Norfolk, Virginia, 23507, United States

Location

Pediatric Hematology and Oncology, Virginia Commonwealth University Health System

Richmond, Virginia, 23298, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Agia Sophia Children's Hospital

Athens, 115 27, Greece

Location

Aglaia Kyriakou - Elpida Children's Oncology Unit

Athens, 115 27, Greece

Location

Semmelweis Egyetem, II. sz. Gyermekgyogyaszati Klinika

Budapest, H-1094, Hungary

Location

Soroka University Medical Center

Beersheba, 84101, Israel

Location

Mayer Children Hospital, Rambam Medical Center

Haifa, 31096, Israel

Location

Hadassah Medical Organization, Ein Kerem

Jerusalem, 91120, Israel

Location

Schneider Children Medical Center of Israel

Petah Tikva, 49202, Israel

Location

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Starship Children's Health

Grafton, Auckland, 1023, New Zealand

Location

Spitalul Clinic Judetean de Urgenta Targu Mures, Clinica pediatrie I

Târgu Mureş, 540136, Romania

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Sheffield Children's Hospital

Sheffield, S10 2TH, United Kingdom

Location

MeSH Terms

Conditions

Pain

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Clinical Leader
• Organization: Purdue Pharma L.P.

800-733-1333

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2010
• First Posted: September 1, 2010
• Study Start: November 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 23, 2020
• Results First Posted: February 6, 2015

Record last verified: 2020-03

Locations

ES (1); GB (1); US (35); IL (5); HU (1); GR (2); NZ (1); RO (1)