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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Open-label, 2 part, ascending dose, single and multiple dose q4-6 hrs up to 48 hrs
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Stanford University School of Medicine
Stanford, California, United States
The Children's Hospital
Aurora, Colorado, United States
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
Time frame: 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.
Time frame: first dose through 48 hours after first dose
AUC(0-t) of Single Dose of Oxymorphone by Treatment Group
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Ct), calculated by linear trapezoidal rule
Time frame: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
AUC(0-inf) of Single Dose of Oxymorphone by Treatment Group
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
Time frame: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
Cmax of Single Dose of Oxymorphone by Treatment Group
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Time frame: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
Tmax of Single Dose of Oxymorphone by Treatment Group
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Children's Research Institute
Washington D.C., District of Columbia, United States
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Hershey Medical Center
Hershey, Pennsylvania, United States
The Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
...and 1 more locations
Tmax: The time at which Cmax was observed
Time frame: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
Terminal Rate Constant of Single Dose of Oxymorphone by Treatment Group
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)
Time frame: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
Terminal Half-life of Single Dose of Oxymorphone by Treatment Group
t½: Terminal half-life, calculated as terminal rate constant/(ln 2) (single-dose period only)
Time frame: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h