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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Oxymorphone IR


Participation Criteria
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Eligibility Criteria
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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: Known allergy to, or a significant reaction to, oxymorphone or another opioid Life expectancy of < 4 weeks Positive pregnancy test at screening

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxymorphone IR<br>Open-Label, 2 part ascending-dose multicenter study | Drug: Oxymorphone IR<br>* Open-label, 2 part, ascending dose, single and multiple dose q4-6 hrs up to 48 hrs<br>* Other names: Opana IR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h | 
| Tmax of Single Dose of Oxymorphone by Treatment Group | Tmax: The time at which Cmax was observed | 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) | 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) | Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid tolerant, Pediatric, Pain, Non malignant, Malignant