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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

Tracking Information
First Submitted Date  ICMJE December 2, 2008
First Posted Date  ICMJE December 3, 2008
Results First Submitted Date  ICMJE December 20, 2018
Results First Posted Date  ICMJE February 27, 2019
Last Update Posted Date February 27, 2019
Actual Study Start Date  ICMJE February 17, 2009
Actual Primary Completion Date April 18, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 2, 2008)
During the Single-Dose Period, the safety of oxymorphone IR in children >12-17 years requiring an opioid to treat their acute postoperative pain of various etiologies will be assessed. [ Time Frame: From baseline up to 4 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2019)
  • 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)
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Pain
Intervention  ICMJE Drug: Oxymorphone IR
Open-label, 2 part, ascending dose, single and multiple dose q4-6 hrs up to 48 hrs
Other Name: Opana IR
Study Arms  ICMJE Experimental: Oxymorphone IR
Open-Label, 2 part ascending-dose multicenter study
Intervention: Drug: Oxymorphone IR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2019)
58
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2008)
48
Actual Study Completion Date  ICMJE April 18, 2011
Actual Primary Completion Date April 18, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00801398
Other Study ID Numbers  ICMJE EN3203-010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Endo Pharmaceuticals
Study Sponsor  ICMJE Endo Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Study Director Endo Pharmaceuticals
PRS Account Endo Pharmaceuticals
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP