An Open-Label Single-Dose And Randomized, Double-Blind, Placebo-Controlled Multiple-Dose Study To Evaluate The Efficacy, Safety, Tolerability, And Pharmacokinetics Of Oxymorphone Hydrochloride (HCl) For Acute Moderate To Severe Postoperative Pain In Pediatric Subjects

Endo Pharmaceuticals3 sites in 1 country28 target enrollmentApril 2016

ConditionsPost-Operative Pain Acute Pain

InterventionsOxymorphone HCl Placebo

DrugsOxymorphone HCl Placebo

Overview

Phase: Phase 3
Intervention: Oxymorphone HCl
Conditions: Post-Operative Pain
Sponsor: Endo Pharmaceuticals
Enrollment: 28
Locations: 3
Primary Endpoint: Cumulative Total Amount of Morphine Rescue Medication Required for Analgesia in the Active Treatment Group (Single Dose)
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to evaluate the efficacy, tolerability, safety and pharmacokinetics of Oxymorphone HCl as an analgesic for acute moderate to severe post-operative pain in pediatric subjects.

Registry

clinicaltrials.gov

Start Date

April 2016

End Date

September 15, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Endo Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Is male or female \<2 years of age at the time of surgery.
•Must weigh at least 3 kg.
•Is scheduled to have a surgical procedure for which opioid analgesia will be needed to manage postoperative pain for at least 18 hours following intraoperative and/or postoperative IV analgesia.
•Is generally healthy as documented by medical history; physical examination (including, but not limited to, the cardiovascular, gastrointestinal, respiratory, and central nervous systems); vital sign assessments; 12-lead electrocardiograms (EKGs); clinical laboratory assessments; and general observations. Any abnormalities or deviations from the acceptable range that might be considered clinically relevant by the study physician or investigator will be evaluated on a case-by-case basis, agreed upon by the Principal Investigator (or sub-investigator), and documented in study files before enrolling the subject in the study.
•The subject's parent or guardian has been informed of the nature of the study and has provided written informed consent.
•Postoperative:
•Is anticipated to require an analgesic regimen using a short-acting opioid (non-oxycodone or non-oxymorphone) analgesic after surgery (according to standard of care (SOC) as defined in the protocol).
•Is an inpatient expected to be hospitalized for 24 hours after dosing with study drug.
•Has an indwelling access catheter for blood sampling.
•For Groups A and B: Has demonstrated signs of tolerating oral intake. All infants and children should be able to demonstrate strong suck and swallow reflexes and neurologic alertness and stability sufficient to handle oral secretions.

Exclusion Criteria

•Subjects who meet any of the following criteria will not be eligible to participate in the study:
•Has the presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or nervous system(s) or psychiatric disease that would contraindicate participation, as determined by the Investigator.
•Has any clinical laboratory test result outside the accepted range that has been confirmed upon re-examination and deemed to be clinically significant.
•Has a clinically significant illness or condition any time before dosing with study drug that would contraindicate participation, as determined by the Investigator.
•Has a life expectancy \<8 weeks.
•For age groups A and B: Has a malabsorption, gastroenterologic, or abdominal condition that would interfere with the absorption of study drug.
•Has evidence of increased intracranial pressure.
•Has a respiratory condition requiring intubation or resulting in active bronchiolitis, asthma, stridor, or difficulty breathing due to congestion and increased nasal secretions, including oxygen (O2) saturation ≤92%.
•Has a history of seizures.
•Subject (and/or mother if subject is nursing) has used medications with actions characteristic of monoamine oxidase inhibitors (MAOIs) within 14 days before the start of the study drug is prohibited. Standard daily pediatric multivitamins may be taken until enrollment into the study but will be restricted during the study.

Arms & Interventions

Oxymorphone HCl Open-Label Phase

Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.

Intervention: Oxymorphone HCl

Oxymorphone HCl Multiple-Dose Phase

Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; placebo controlled, randomized, double-blinded multiple-dose phase.

Intervention: Oxymorphone HCl

Placebo

Sodium Chloride 0.9% solution; comparator for multiple-dose phase.

Intervention: Placebo

Outcomes

Primary Outcomes

Cumulative Total Amount of Morphine Rescue Medication Required for Analgesia in the Active Treatment Group (Single Dose)

Time Frame: Up to 24 hours post dose

Cumulative Total Amount of Morphine Rescue Medication Required for Analgesia in the Active Treatment Group Versus Placebo Group (Multiple Dose).

Time Frame: Up to 24 hours post dose

Secondary Outcomes

Assessment of Pain Using the Age Appropriate Scale, Face, Legs, Activity, Cry, Consolability (FLACC) or the Neonatal Infant Pain Scale (NIPS).(Single Dose Phase: at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6 and 8 hours post dose. Multiple Dose Phase: every 0.5 hours up to 24 hours post first dose.)
Pharmacokinetic Variable: Volume of Distribution (Vd)(Single Dose Phase: at 0 (Baseline), 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, and 24 hours post dose. Multiple Dose Phase: Baseline before each dose only)
Pharmacokinetic Variable: Clearance (CL)(Single Dose Phase: at 0 (Baseline), 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, and 24 hours post dose. Multiple Dose Phase: Baseline before each dose)