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

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

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 Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Oxymorphone IR

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine
  • Colorado
    • Aurora, Colorado, United States, 80045
      • The Children's Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's Research Institute
  • Florida
    • Tampa, Florida, United States, 33607
      • St. Joseph's Children's Hospital of Tampa
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Medicine
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Hershey Medical Center
    • Pittsburgh, Pennsylvania, United States, 15213
      • The Children's Hospital of Pittsburgh
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Monroe Carell Jr. Children's Hospital at Vanderbilt
  • Texas
    • Dallas, Texas, United States, 75235
      • University of Texas Southwestern Medical Center at Dallas
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Endo Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2009
• Primary Completion (Actual): April 18, 2011
• Study Completion (Actual): April 18, 2011

Study Registration Dates

• First Submitted: December 2, 2008
• First Submitted That Met QC Criteria: December 2, 2008
• First Posted (Estimate): December 3, 2008

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Pain; Pediatric; Malignant; Opioid tolerant; Non malignant
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Oxymorphone
• Other Study ID Numbers: EN3203-010