Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001
An Open-label, Extension Study to Assess the Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Opioid Experienced Children Who Completed the OTR3001 Study
2 other identifiers
interventional
23
2 countries
14
Brief Summary
The purpose of this study is to characterize the long-term safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid experienced pediatric patients aged 6 to 17 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy who completed the 4 -week treatment period in OTR3001.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 pain
Started Oct 2011
Typical duration for phase_3 pain
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2011
CompletedFirst Posted
Study publicly available on registry
June 9, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedResults Posted
Study results publicly available
January 15, 2015
CompletedSeptember 9, 2015
August 1, 2015
2.2 years
June 7, 2011
January 7, 2015
August 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Number of Participants With Adverse Events as a Measure of Safety.
Safety assessments included adverse events (AEs), vital sign measurements, clinical laboratory test results, and somnolence (University of Michigan Sedation Scale \[UMSS\]). Safety variables were summarized descriptively within age group for the extension safety population.
Up to 6 months (during the study) and 7-10 days poststudy (safety follow-up assessment).
Study Arms (1)
Oxycodone HCl controlled-release
EXPERIMENTALOxycodone hydrochloride controlled-release tablets
Interventions
Oxycodone hydrochloride controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg to 240 mg daily) every 12 hours.
Eligibility Criteria
You may qualify if:
- Male and female patients aged 6 to 17 years, inclusive, who completed the 4-week study drug treatment in study OTR3001 and who, based on the investigator's judgment, will benefit from continuing treatment with oxycodone HCl CR 20 to 240 mg/day for the management of moderate to severe malignant or nonmalignant pain;
- Patients must have tolerated the oxycodone HCl CR therapy in OTR3001 as demonstrated at the start of the study;
- Patients must be willing and able to swallow the oxycodone HCl CR tablets whole.
You may not qualify if:
- Patients with ongoing adverse events in OTR3001 that, in the investigator's opinion, disqualify them from participation in the study;
- Female patients who are pregnant or lactating;
- Patients requiring opioid at doses equivalent to \< 20 mg/day or \> 240 mg/day oxycodone for treatment of their malignant or nonmalignant pain;
- 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 are contraindicated for the use of opioids;
- Patients who are currently being maintained on methadone for pain;
- Patients who have an abnormality on vital signs, physical examination, or laboratory testing significant enough that the investigator deems the patient is not appropriate for the study;
- 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 currently taking an investigational medication/therapy other than the study drug (oxycodone HCl CR) at the start of screening or during the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Purdue Pharma LPlead
Study Sites (14)
Children's Hospital of Alabama
Birmingham, Alabama, 35233, United States
Bayview Research Group, LLC
Paramount, California, 90723, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Jackson Memorial Hospital
Miami, Florida, 33136, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Mercy Clinic Children's Cancer and Hematology Center
St Louis, Missouri, 63141, United States
New York University Langone Medical Center
New York, New York, 10016, United States
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
Presbyterian Blume Pediatric Hematology & Oncology Clinic
Charlotte, North Carolina, 28204, United States
Akron Children's Hospital
Akron, Ohio, 44308, United States
The Children's Hospital at Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73104, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232, United States
Children's Medical Center of Dallas
Dallas, Texas, 75235, United States
Schneider Children Medical Center of Israel
Petah Tikva, 49202, Israel
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Enrollment for study OTR3002 was closed by Purdue Pharma L.P. on 01-January-2014 due to administrative reasons not related to safety. Interpretation is limited by the small number of patients in each age group in this study.
Results Point of Contact
- Title
- Clinical Leader
- Organization
- Purdue Pharma L.P.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2011
First Posted
June 9, 2011
Study Start
October 1, 2011
Primary Completion
December 1, 2013
Study Completion
May 1, 2014
Last Updated
September 9, 2015
Results First Posted
January 15, 2015
Record last verified: 2015-08