Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids
NCT ID: NCT01192295
Last Updated: 2020-03-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
155 participants
INTERVENTIONAL
2010-11-30
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Oxycodone HCl controlled-release
Oxycodone hydrochloride (HCl) controlled-release (CR)
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
6 Years
16 Years
ALL
No
Sponsors
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Purdue Pharma LP
INDUSTRY
Responsible Party
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Locations
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Children's Hospital of Alabama
Birmingham, Alabama, United States
University of South Alabama, Children's and Women's Hospital
Mobile, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
LS Packard Children's Hospital
Palo Alto, California, United States
Bayview Research Group, LLC
Paramount, California, United States
Shriners Hospitals for Children Northern California
Sacramento, California, United States
The Children's Hospital
Aurora, Colorado, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States
Memorial Regional Hospital
Hollywood, Florida, United States
Jackson Memorial Hospital/University of Miami
Miami, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Children's Memorial Hospital
Chicago, Illinois, United States
University of Kentucky
Lexington, Kentucky, United States
Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States
St. John's Mercy Medical Center
St Louis, Missouri, United States
New York University Langone Medical Center
New York, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Presbyterian Blume Pediatric Hematology and Oncology Clinic
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Akron Children's Hospital
Akron, Ohio, United States
Department of Pediatrics, University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
The Children's Hospital at OUMC
Oklahoma City, Oklahoma, United States
Legacy Emanuel Children's Hospital
Portland, Oregon, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Children's Medical Ctr of Dallas
Dallas, Texas, United States
Research Facility
The Woodlands, Texas, United States
Primary Children's Medical Center
Salt Lake City, Utah, United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States
Pediatric Hematology and Oncology, Virginia Commonwealth University Health System
Richmond, Virginia, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Agia Sophia Children's Hospital
Athens, , Greece
Aglaia Kyriakou - Elpida Children's Oncology Unit
Athens, , Greece
Semmelweis Egyetem, II. sz. Gyermekgyogyaszati Klinika
Budapest, , Hungary
Soroka University Medical Center
Beersheba, , Israel
Mayer Children Hospital, Rambam Medical Center
Haifa, , Israel
Hadassah Medical Organization, Ein Kerem
Jerusalem, , Israel
Schneider Children Medical Center of Israel
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Starship Children's Health
Grafton, Auckland, New Zealand
Spitalul Clinic Judetean de Urgenta Targu Mures, Clinica pediatrie I
Târgu Mureş, , Romania
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Sheffield Children's Hospital
Sheffield, , United Kingdom
Countries
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Other Identifiers
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2010-020471-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
OTR3001
Identifier Type: -
Identifier Source: org_study_id
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