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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00801398
Recruitment Status : Completed
First Posted : December 3, 2008
Results First Posted : February 27, 2019
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Oxymorphone IR Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : February 17, 2009
Actual Primary Completion Date : April 18, 2011
Actual Study Completion Date : April 18, 2011

Resource links provided by the National Library of Medicine


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 Name: Opana IR




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00801398


Locations
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United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Colorado
The Children's Hospital
Aurora, Colorado, United States, 80045
United States, District of Columbia
Children's Research Institute
Washington, District of Columbia, United States, 20010
United States, Florida
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, United States, 33607
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Pennsylvania
Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
The Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75235
United States, Washington
University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
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Study Director: Study Director Endo Pharmaceuticals
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Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00801398    
Other Study ID Numbers: EN3203-010
First Posted: December 3, 2008    Key Record Dates
Results First Posted: February 27, 2019
Last Update Posted: February 27, 2019
Last Verified: December 2018
Keywords provided by Endo Pharmaceuticals:
Opioid tolerant
Pediatric
Pain
Non malignant
Malignant
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Oxymorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia