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OpenTrials
Completed

NCT Number: NCT00801398

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

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Arkansas Children's Hospital, Little Rock, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxymorphone IR

Drug

Open-label, 2 part, ascending dose, single and multiple dose q4-6 hrs up to 48 hrs

Other names: Opana IR

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)

  6. 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)

Sponsors and collaborators

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 3, 2008
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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