Know Cancer

or
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)
Both
Pain

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
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.

Type of Study:

Interventional

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:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

OTR3001

NCT ID:

NCT01192295

Start Date:

November 2010

Completion Date:

August 2013

Related Keywords:

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

Name

Location

Sinai Hospital of BaltimoreBaltimore, Maryland  21225
Loma Linda University Medical CenterLoma Linda, California  92354
Rush University Medical CenterChicago, Illinois  60612-3824
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's Hospital of Orange CountyOrange, California  92668
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
Children's Hospital Central CaliforniaMadera, California  93638-8762
Southern Illinois University School of MedicineSpringfield, Illinois  62794-9658
Children's Hospitals and Clinics of MinnesotaSaint Paul, Minnesota  55102
Primary Children's Medical CenterSalt Lake City, Utah  84113-1100
Alfred I. duPont Hospital for ChildrenWilmington, Delaware  19803
Akron Children's HospitalAkron, Ohio  44308-1062
Children's Hospital of Pittsburgh of UPMCPittsburgh, Pennsylvania  15213
St. John's Mercy Medical CenterSaint Louis, Missouri  63141
Yale-New Haven HospitalNew Haven, Connecticut  06504
Children's Hospital of AlabamaBirmingham, Alabama  35233
Connecticut Children's Medical CenterHartford, Connecticut  06106
Duke University Medical CenterDurham, North Carolina  27710
Children's Hospital of WisconsinMilwaukee, Wisconsin  53201
Legacy Emanuel Children's HospitalPortland, Oregon  97227
University of ChicagoChicago, Illinois  60637
Tampa General HospitalTampa, Florida  33606
University of KentuckyLexington, Kentucky  40536-0098
Stony Brook University HospitalStony Brook, New York  11794-8174
Children's Memorial HospitalChicago, Illinois  60614
Palm Beach Research CenterWest Palm Beach, Florida  33409
Dana Farber Cancer Institute (DFCI)Boston, Massachusetts  02215
Memorial Regional HospitalHollywood, Florida  33021
CHRISTUS Santa Rosa Children's HospitalSan Antonio, Texas  78207
New York University Langone Medical CenterNew York, New York  10016
The Children'S HospitalDenver, Colorado  80218
Lynn Institute of the RockiesColorado Springs, Colorado  80909
Helen DeVos Children's HospitalGrand Rapids, Michigan  49503
Penn State Hershey Children's HospitalHershey, Pennsylvania  17033
Ochsner Medical CenterNew Orleans, Louisiana  70121
Monroe Carell Jr. Children's Hospital at VanderbiltNashville, Tennessee  37232
Children's Specialty Center of NevadaLas Vegas, Nevada  89109
University of South Alabama, Children's and Women's HospitalMobile, Alabama  36604
Maricopa Medical CenterPhoenix, Arizona  85008
Department of Pediatrics - UCLA David Geffen School of MedicineLos Angeles, California  90095
LS Packard Children's HospitalPalo Alto, California  94304
Bayview Research Group, LLCParamount, California  90723
Sanitas ResearchCoral Gables, Florida  33134
Jackson Memorial Hospital/University of MiamiMiami, Florida  33136
The Children's Hospital at the Medical Center of Central GeorgiaMacon, Georgia  31201
Floating Hospital for Children at Tufts Medical CenterBoston, Massachusetts  02111
St. John Hospital & Medical CenterDetroit, Michigan  48236
Apex Medical Research, MI, Inc.Flint, Michigan  48504
Children's Blood Disorders & Cancer UnitColumbia, Missouri  65201
Morristown Medical CenterMorristown, New Jersey  07962-1956
Presbyterian Blume Pediatric Hematology and Oncology ClinicCharlotte, North Carolina  28204
Cleveland Clinic Children's Hospital for RehabilitationCleveland, Ohio  44104
University Hospital - Case Medical Center Rainbow Babies & Children's HospitalCleveland, Ohio  44106
Lynn Health Science InstituteOklahoma City, Oklahoma  73112
Department of Pediatrics, University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
The Children's Hospital at OUMCOklahoma City, Oklahoma  73104
Children's Medical Ctr of DallasDallas, Texas  75235
Research FacilityThe Woodlands, Texas  77381
Pediatric Hematology and Oncology, Virginia Commonwealth University Health SystemRichmond, Virginia  23298
Carillion Clinic Children's HospitalRoanoke, Virginia  24014
University of Washington School of Medicine - Harborview Medical CenterSeattle, Washington  98104-2420