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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 18, 2011

Interventions

  • Drug: Oxymorphone IR
    • Open-label, 2 part, ascending dose, single and multiple dose q4-6 hrs up to 48 hrs

Arms, Groups and Cohorts

  • Experimental: Oxymorphone IR
    • Open-Label, 2 part ascending-dose multicenter study

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • AUC(0-t) of Single Dose of Oxymorphone by Treatment Group
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Endo Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Study Director, Study Director, Endo Pharmaceuticals

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