Know Cancer

forgot password

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

Phase 3
6 Years
16 Years
Open (Enrolling)

Thank you

Trial Information

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

Inclusion 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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

The number of participants with adverse events as a measure of safety.

Outcome Time Frame:

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

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

November 2010

Completion Date:

August 2013

Related Keywords:

  • Pain
  • Malignant pain
  • Nonmalignant pain
  • Pediatric
  • Opioid
  • Moderate to severe malignant or nonmalignant pain



Sinai Hospital of Baltimore Baltimore, Maryland  21225
Loma Linda University Medical Center Loma Linda, California  92354
Rush University Medical Center Chicago, Illinois  60612-3824
Children's Hospital Los Angeles Los Angeles, California  90027-0700
Children's Hospital of Orange County Orange, California  92668
Phoenix Children's Hospital Phoenix, Arizona  85016-7710
Children's Hospital Central California Madera, California  93638-8762
Southern Illinois University School of Medicine Springfield, Illinois  62794-9658
Children's Hospitals and Clinics of Minnesota Saint Paul, Minnesota  55102
Primary Children's Medical Center Salt Lake City, Utah  84113-1100
Alfred I. duPont Hospital for Children Wilmington, Delaware  19803
Akron Children's Hospital Akron, Ohio  44308-1062
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania  15213
St. John's Mercy Medical Center Saint Louis, Missouri  63141
Yale-New Haven Hospital New Haven, Connecticut  06504
Children's Hospital of Alabama Birmingham, Alabama  35233
Connecticut Children's Medical Center Hartford, Connecticut  06106
Duke University Medical Center Durham, North Carolina  27710
Children's Hospital of Wisconsin Milwaukee, Wisconsin  53201
Legacy Emanuel Children's Hospital Portland, Oregon  97227
University of Chicago Chicago, Illinois  60637
Tampa General Hospital Tampa, Florida  33606
University of Kentucky Lexington, Kentucky  40536-0098
Stony Brook University Hospital Stony Brook, New York  11794-8174
Children's Memorial Hospital Chicago, Illinois  60614
Palm Beach Research Center West Palm Beach, Florida  33409
Dana Farber Cancer Institute (DFCI) Boston, Massachusetts  02215
Memorial Regional Hospital Hollywood, Florida  33021
CHRISTUS Santa Rosa Children's Hospital San Antonio, Texas  78207
New York University Langone Medical Center New York, New York  10016
The Children'S Hospital Denver, Colorado  80218
Lynn Institute of the Rockies Colorado Springs, Colorado  80909
Helen DeVos Children's Hospital Grand Rapids, Michigan  49503
Penn State Hershey Children's Hospital Hershey, Pennsylvania  17033
Ochsner Medical Center New Orleans, Louisiana  70121
Monroe Carell Jr. Children's Hospital at Vanderbilt Nashville, Tennessee  37232
Children's Specialty Center of Nevada Las Vegas, Nevada  89109
University of South Alabama, Children's and Women's Hospital Mobile, Alabama  36604
Maricopa Medical Center Phoenix, Arizona  85008
Department of Pediatrics - UCLA David Geffen School of Medicine Los Angeles, California  90095
LS Packard Children's Hospital Palo Alto, California  94304
Bayview Research Group, LLC Paramount, California  90723
Sanitas Research Coral Gables, Florida  33134
Jackson Memorial Hospital/University of Miami Miami, Florida  33136
The Children's Hospital at the Medical Center of Central Georgia Macon, Georgia  31201
Floating Hospital for Children at Tufts Medical Center Boston, Massachusetts  02111
St. John Hospital & Medical Center Detroit, Michigan  48236
Apex Medical Research, MI, Inc. Flint, Michigan  48504
Children's Blood Disorders & Cancer Unit Columbia, Missouri  65201
Morristown Medical Center Morristown, New Jersey  07962-1956
Presbyterian Blume Pediatric Hematology and Oncology Clinic Charlotte, North Carolina  28204
Cleveland Clinic Children's Hospital for Rehabilitation Cleveland, Ohio  44104
University Hospital - Case Medical Center Rainbow Babies & Children's Hospital Cleveland, Ohio  44106
Lynn Health Science Institute Oklahoma City, Oklahoma  73112
Department of Pediatrics, University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
The Children's Hospital at OUMC Oklahoma City, Oklahoma  73104
Children's Medical Ctr of Dallas Dallas, Texas  75235
Research Facility The Woodlands, Texas  77381
Pediatric Hematology and Oncology, Virginia Commonwealth University Health System Richmond, Virginia  23298
Carillion Clinic Children's Hospital Roanoke, Virginia  24014
University of Washington School of Medicine - Harborview Medical Center Seattle, Washington  98104-2420