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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Purdue Pharma LP
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT01192295
First received: August 30, 2010
Last updated: June 17, 2014
Last verified: June 2014
  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.


Condition Intervention Phase
Pain
Drug: Oxycodone HCl controlled-release tablets
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:
  • The number of participants with adverse events as a measure of safety. [ Time Frame: Up to 4 weeks (during the study) and 7-10 days poststudy (safety follow-up assessment). ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To characterize the efficacy and provide additional pharmacokinetics (PK) data of oxycodone hydrochloride controlled-release tablets [ Time Frame: 2-4 and 4-6 hours (hrs) after the first dose on Day 1 and immediately pre-dose and 2-4 hrs after dose at Visit 2 and/or Visit 3. ] [ Designated as safety issue: No ]
    To characterize the efficacy and provide additional pharmacokinetics (PK) data for a population PK model of oxycodone hydrochloride controlled-release tablets in opioid tolerant pediatric patients aged 6 to 16 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy.


Estimated Enrollment: 154
Study Start Date: November 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxycodone HCl controlled-release
Oxycodone hydrochloride (HCl) controlled-release (CR)
Drug: Oxycodone HCl controlled-release tablets
Oxycodone HCl controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg - 240 mg daily) every 12 hours.
Other Name: OxyContin

  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192295

Contacts
Contact: Eduardo Rodenas, MD 203-588-7660 Eduardo.Rodenas@pharma.com

  Hide Study Locations
Locations
United States, Alabama
Children's Hospital of Alabama Completed
Birmingham, Alabama, United States, 35233
University of South Alabama, Children's and Women's Hospital Completed
Mobile, Alabama, United States, 36604
United States, Arizona
Maricopa Medical Center Withdrawn
Phoenix, Arizona, United States, 85008
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016
United States, California
Loma Linda University Medical Center Withdrawn
Loma Linda, California, United States, 92354
Department of Pediatrics - UCLA David Geffen School of Medicine Withdrawn
Los Angeles, California, United States, 90095
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Children's Hospital Central California Withdrawn
Madera, California, United States, 93636
Children's Hospital of Orange County Completed
Orange, California, United States, 92868
LS Packard Children's Hospital Terminated
Palo Alto, California, United States, 94304
Bayview Research Group, LLC Completed
Paramount, California, United States, 90723
Shriners Hospitals for Children Northern California Recruiting
Sacramento, California, United States, 95817
United States, Colorado
The Children's Hospital Recruiting
Aurora, Colorado, United States, 80045
Lynn Institute of the Rockies Withdrawn
Colorado Springs, Colorado, United States, 80907
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Yale-New Haven Hospital Withdrawn
New Haven, Connecticut, United States, 06520
United States, Delaware
Alfred I. duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
United States, Florida
Sanitas Research Completed
Coral Gables, Florida, United States, 33134
Memorial Regional Hospital Completed
Hollywood, Florida, United States, 33021
Jackson Memorial Hospital/University of Miami Recruiting
Miami, Florida, United States, 33136
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Palm Beach Research Center Withdrawn
West Palm Beach, Florida, United States, 33409
United States, Georgia
The Children's Hospital at the Medical Center of Central Georgia Withdrawn
Macon, Georgia, United States, 31201
United States, Illinois
Children's Memorial Hospital Recruiting
Chicago, Illinois, United States, 60614
University of Chicago Withdrawn
Chicago, Illinois, United States, 60637
Rush University Medical Center Withdrawn
Chicago, Illinois, United States, 60612
Southern Illinois University School of Medicine Withdrawn
Springfield, Illinois, United States, 62702
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
United States, Louisiana
Ochsner Medical Center Withdrawn
New Orleans, Louisiana, United States, 70121
United States, Maryland
Sinai Hospital of Baltimore Withdrawn
Baltimore, Maryland, United States, 21215
United States, Massachusetts
Floating Hospital for Children at Tufts Medical Center Withdrawn
Boston, Massachusetts, United States, 02111
Dana Farber Cancer Institute (DFCI) Withdrawn
Boston, Massachusetts, United States, 02215
United States, Michigan
St. John Hospital & Medical Center Withdrawn
Detroit, Michigan, United States, 48236
Apex Medical Research, MI, Inc. Withdrawn
Flint, Michigan, United States, 48504
Helen DeVos Children's Hospital Terminated
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Children's Hospitals and Clinics of Minnesota Withdrawn
Minneapolis, Minnesota, United States, 55404
United States, Missouri
Children's Blood Disorders & Cancer Unit Recruiting
Columbia, Missouri, United States, 65201
St. John's Mercy Medical Center Completed
St. Louis, Missouri, United States, 63141
United States, Nevada
Children's Specialty Center of Nevada Withdrawn
Las Vegas, Nevada, United States, 89109
United States, New Jersey
Morristown Medical Center Withdrawn
Morristown, New Jersey, United States, 07962-1956
United States, New York
New York University Langone Medical Center Recruiting
New York, New York, United States, 10016
Stony Brook University Hospital Recruiting
Stony Brook, New York, United States, 11794
United States, North Carolina
Presbyterian Blume Pediatric Hematology and Oncology Clinic Recruiting
Charlotte, North Carolina, United States, 28204
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 22710
United States, Ohio
Akron Children's Hospital Recruiting
Akron, Ohio, United States, 44308
Cleveland Clinic Children's Hospital for Rehabilitation Withdrawn
Cleveland, Ohio, United States, 44104
University Hospital - Case Medical Center Rainbow Babies & Children's Hospital Withdrawn
Cleveland, Ohio, United States, 44106
United States, Oklahoma
Lynn Health Science Institute Withdrawn
Oklahoma City, Oklahoma, United States, 73112
Department of Pediatrics, University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
The Children's Hospital at OUMC Completed
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Legacy Emanuel Children's Hospital Recruiting
Portland, Oregon, United States, 97227
United States, Pennsylvania
Penn State Hershey Children's Hospital Withdrawn
Hershey, Pennsylvania, United States, 17033
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Children's Medical Ctr of Dallas Recruiting
Dallas, Texas, United States, 75235
CHRISTUS Santa Rosa Children's Hospital Withdrawn
San Antonio, Texas, United States, 78207-3198
Research Facility Completed
The Woodlands, Texas, United States, 77381
United States, Utah
Primary Children's Medical Center Terminated
Salt Lake City, Utah, United States, 84113
United States, Virginia
Children's Hospital of the King's Daughters Recruiting
Norfolk, Virginia, United States, 23507
Pediatric Hematology and Oncology, Virginia Commonwealth University Health System Completed
Richmond, Virginia, United States, 23298
Carillion Clinic Children's Hospital Withdrawn
Roanoke, Virginia, United States, 24014
United States, Washington
University of Washington School of Medicine - Harborview Medical Center Withdrawn
Seattle, Washington, United States, 98104-2420
United States, Wisconsin
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Belgium
Universitair Ziekenhuis Gent Withdrawn
Gent, Belgium, 9000
U.Z Leuven - Department of Pediatric Hematology-Oncology Withdrawn
Leuven, Belgium, 3000
Estonia
Tallinn Children's Hospital Withdrawn
Tallinn, Estonia, 13419
Tartu University Hospital Withdrawn
Tartu, Estonia, 51014
Finland
Kuopio University Hospital/Operative Services and Intensive Care Withdrawn
Kuopio, Finland, FI-70211
Turku University Central Hospital/Pediatric Clinic Withdrawn
Turku, Finland, FI-20521
Germany
Klinik und Poliklinik für Kinder- und Jugendheilkunde Withdrawn
Greifswald, Germany, 17475
Greece
AHEPA University General Hospital of Thessaloniki - 2nd University Pediatric Clinic Withdrawn
Thessaloniki, Makedonia, Greece, 546 36
Agia Sophia Children's Hospital Completed
Athens, Greece, 115 27
Aglaia Kyriakou - Elpida Children's Oncology Unit Completed
Athens, Greece, 115 27
Aglaia Kyriakou Children's Hospital Withdrawn
Athens, Greece, 115 27
Guatemala
Clinica Medica Especializada en Pediatria Withdrawn
Guatemala, Guatemala, 01010
Clinica Privada Withdrawn
Guatemala, Guatemala, 01010
Clinicas Punto Medico Withdrawn
Guatemala, Guatemala, 01011
Clinica Especializada en Ortopedia y Traumatologia Withdrawn
Guatemala, Guatemala, 01015
Unidad de Terapia Intensiva Withdrawn
Quetzaltenango, Guatemala, 09001
Clinica Medica Especializada en Pediatria Centro Galo Withdrawn
Quetzaltenango, Guatemala, 09001
Hungary
Semmelweis Egyetem, II. sz. Gyermekgyogyaszati Klinika Completed
Budapest, Hungary, H-1094
Magyarorszagi Reformatus Egyhaz, Bethesda Gyermekkorhaza Withdrawn
Budapest, Hungary, H-1146
Israel
Soroka University Medical Center Recruiting
Beer Sheva, Israel, 84101
Mayer Children Hospital, Rambam Medical Center Recruiting
Haifa, Israel, 31096
Hadassah Medical Organization, Ein Kerem Recruiting
Jerusalem, Israel, 91120
Schneider Children Medical Center of Israel Recruiting
Petach Tikva, Israel, 49202
Sheba Medical Center Recruiting
Tel HaShomer, Israel, 52621
New Zealand
Starship Children's Health Completed
Grafton, Auckland, New Zealand, 1023
Poland
Dzieciecy Szpital Kliniczny im. Prof. Antoniego Gebali Withdrawn
Lublin, Poland, 20-093
Instytut Matki i Dziecka Withdrawn
Warszawa, Poland, 01-211
Instytut "Pomnik - Centrum Zdrowia Dziecka", Klinika Onkologii Withdrawn
Warszawa, Poland, 04-730
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu Withdrawn
Wroclaw, Poland, 50-345
Romania
Institutul Oncologic "Prof. Dr. I. Chiricuta", Sectia de Oncopediatrie Withdrawn
Cluj, Romania, 400015
Spitalul Clinic de Urgenta pentru Copii "Sfanta Maria" Iasi, Sectia de Hematologie si Oncologie pediatrica Withdrawn
Iasi, Romania, 700309
Spitalul Clinic Judetean de Urgenta Targu Mures, Clinica pediatrie I Terminated
Targu Mures, Romania, 540136
Spain
Hospital de la Santa Creu i Sant Pau Completed
Barcelona, Spain, 08025
Hospital Sant Joan de Deu Withdrawn
Barcelona, Spain, 08950
Hospital Universitario Vall d'Hebron Withdrawn
Barcelona, Spain, 08035
Sweden
Universitetssjukhuset i Linkoping Withdrawn
Linkoping, Sweden, 581 85
Norrlands Universitetssjukhus Withdrawn
Umea, Sweden, 901 85
United Kingdom
Sheffield Children's Hospital Recruiting
Sheffield, United Kingdom, S10 2TH
Sponsors and Collaborators
Purdue Pharma LP
  More Information

Additional Information:
No publications provided

Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT01192295     History of Changes
Other Study ID Numbers: OTR3001, 2010-020471-23
Study First Received: August 30, 2010
Last Updated: June 17, 2014
Health Authority: United States: Food and Drug Administration
Estonia: The State Agency of Medicine
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Israel: Ministry of Health
New Zealand: Medsafe
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Poland: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Romania: Ministry of Public Health
Guatemala: Ministry of Public Health and Social Assistance
Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Purdue Pharma LP:
Malignant pain
Nonmalignant pain
Pediatric
Opioid
Moderate to severe malignant or nonmalignant pain

Additional relevant MeSH terms:
Analgesics, Opioid
Oxycodone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on July 20, 2014