Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.

Phase 3

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Oxymorphone IR	Oxymorphone IR	Open-Label, 2 part ascending-dose multicenter study

Primary Outcome Measures

Name	Time	Method
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	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	Change from Baseline in 100-mm Visual Analog Scales (VAS) in Multiple Dose of Oxymorphone IR Tablet
Subjects Taking Rescue Medication	first dose through 48 hours after first dose	Percentages are based on the number of subjects in each treatment group.

Secondary Outcome Measures

Name	Time	Method
AUC(0-t) of Single Dose of Oxymorphone by Treatment Group	Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h	AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Ct), calculated by linear trapezoidal rule
AUC(0-inf) of Single Dose of Oxymorphone by Treatment Group	Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h	AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Ct/terminal rate constant (single-dose period only), where Ct is the concentration at the time of the last quantifiable concentration
Cmax of Single Dose of Oxymorphone by Treatment Group	Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h	Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Tmax of Single Dose of Oxymorphone by Treatment Group	Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h	Tmax: The time at which Cmax was observed
Terminal Rate Constant of Single Dose of Oxymorphone by Treatment Group	Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h	λ: Terminal rate constant, calculated as the negative slope of the ln-linear portion of the terminal plasma concentration-time curve (single-dose period only)
Terminal Half-life of Single Dose of Oxymorphone by Treatment Group	Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h	t½: Terminal half-life, calculated as terminal rate constant/(ln 2) (single-dose period only)

Locations (11): Children's Research Institute
🇺🇸
Washington, District of Columbia, United States
St. Joseph's Children's Hospital of Tampa
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Tampa, Florida, United States
Hershey Medical Center
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Hershey, Pennsylvania, United States
University of Texas Southwestern Medical Center at Dallas
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Dallas, Texas, United States
Indiana University School of Medicine
🇺🇸
Indianapolis, Indiana, United States
University of Washington
🇺🇸
Seattle, Washington, United States
Arkansas Children's Hospital
🇺🇸
Little Rock, Arkansas, United States
The Children's Hospital
🇺🇸
Aurora, Colorado, United States
The Children's Hospital of Pittsburgh
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Pittsburgh, Pennsylvania, United States
Stanford University School of Medicine
🇺🇸
Stanford, California, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
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Nashville, Tennessee, United States