Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.
An Open-Label, Ascending, Two-Part, Single- and Multiple-Dose Evaluation of the Safety, Pharmacokinetics, and Effectiveness of Oxymorphone for Acute Postoperatiave Pain in Pediatric Subjects
1 other identifier
interventional
58
1 country
11
Brief Summary
When post-operative parenteral analgesia is discontinued, oral dosing with study medication may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS (pain intensity score greater than or equal to 40). This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 postoperative-pain
Started Feb 2009
Typical duration for phase_3 postoperative-pain
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2008
CompletedFirst Posted
Study publicly available on registry
December 3, 2008
CompletedStudy Start
First participant enrolled
February 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 18, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 18, 2011
CompletedResults Posted
Study results publicly available
February 27, 2019
CompletedFebruary 27, 2019
December 1, 2018
2.2 years
December 2, 2008
December 20, 2018
February 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet
Change from Baseline in 100-mm Visual Analog Scales (VAS) in Multiple Dose of Oxymorphone IR Tablet
Single Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h or Rescue; Multiple Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h, subsequent doses every 4-6 hours (Multiple Dose #1-11), and Early Termination
Subjects Taking Rescue Medication
Percentages are based on the number of subjects in each treatment group.
first dose through 48 hours after first dose
Secondary Outcomes (6)
AUC(0-t) of Single Dose of Oxymorphone by Treatment Group
Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
AUC(0-inf) of Single Dose of Oxymorphone by Treatment Group
Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
Cmax of Single Dose of Oxymorphone by Treatment Group
Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
Tmax of Single Dose of Oxymorphone by Treatment Group
Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
Terminal Rate Constant of Single Dose of Oxymorphone by Treatment Group
Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
- +1 more secondary outcomes
Study Arms (1)
Oxymorphone IR
EXPERIMENTALOpen-Label, 2 part ascending-dose multicenter study
Interventions
Open-label, 2 part, ascending dose, single and multiple dose q4-6 hrs up to 48 hrs
Eligibility Criteria
You may qualify if:
- Male or female \> 12 to 17 years of age, inclusive
- Weigh at least 50 kg
- Postoperative oral opioid analgesia required for at least 24 hours or 48 hours following postoperataive parenteral analgesia
- Are expected to be hospitalized for the duration of the study
You may not qualify if:
- Known allergy to, or a significant reaction to, oxymorphone or another opioid
- Life expectancy of \< 4 weeks
- Positive pregnancy test at screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Stanford University School of Medicine
Stanford, California, 94305, United States
The Children's Hospital
Aurora, Colorado, 80045, United States
Children's Research Institute
Washington D.C., District of Columbia, 20010, United States
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, 33607, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
The Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235, United States
University of Washington
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.
Results Point of Contact
- Title
- Saji Vijayan
- Organization
- Endo Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Study Director
Endo Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
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
December 2, 2008
First Posted
December 3, 2008
Study Start
February 17, 2009
Primary Completion
April 18, 2011
Study Completion
April 18, 2011
Last Updated
February 27, 2019
Results First Posted
February 27, 2019
Record last verified: 2018-12