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
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The number of participants with adverse events as a measure of safety.
Up to 4 weeks (during the study) and 7-10 days poststudy (safety follow-up assessment).
Yes
United States: Food and Drug Administration
OTR3001
NCT01192295
November 2010
August 2013
Name | Location |
---|---|
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 |