Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects

Study Description

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Brief Summary:

The purpose of this study is to evaluate the effectiveness, tolerability, and safety of oxymorphone immediate release (IR) oral liquid as an analgesic for acute postoperative pain in pediatric subjects.

Condition or disease	Intervention/treatment	Phase
Post Operative Pain	Drug: oxymorphone HCl	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	72 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	An Open-Label, Non-randomized, Multicenter, Ascending Dose by Age, Single- and Multiple-Dose Evaluation of the Effectiveness, Safety, and Tolerability of Oral Liquid Oxymorphone HCl Immediate-Release Oral Liquid for Acute Postoperative Pain in Pediatric Subjects
Study Start Date :	December 2010
Estimated Primary Completion Date :	February 2018
Estimated Study Completion Date :	February 2018

Arms and Interventions

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Arm	Intervention/treatment
Experimental: CII Drug; Open Label	Drug: oxymorphone HCl; Comparison of different dosages of drug, 0.05mg/kg, 0.10mg/kg, 0.15mg/kg or 0.20mg/kg oral liquid oxymorphone; Other Name: Opana

Outcome Measures

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Primary Outcome Measures :

1. Assessment of safety and tolerability will be based on the incidence of Adverse Events(AEs), AEs resulting in discontinuation and serious adverse events [ Time Frame: Safety = Up to 48 hours ]
   Single Dose (pain assessment) Effectiveness = baseline, .25. .5. 1. 1.5. 2, 4, 6, 8, 12, 24 post dose; Multi-Dose (pain assessment) Effectiveness= baseline, .5, 1, 1.5, and 2 hrs post dose 1; and immediately prior to all remaining doses administered up through 48 hrs.

Secondary Outcome Measures :

1. To determine and report the the pharmacokinetic profile of oxymorphone IR oral liquid in pediatric subjects in order to determine appropriate dosing recommendations. [ Time Frame: Up to 48 Hours ]
   Single-Dose PK: baseline, .25, .5, 1, 1.5, 2, 4, 6, 8, 12, & 24 hrs; Multi-Dose PK = baseline, .5, 1, 1.5, and 2 hrs post dose 1; immediately prior to doses 2, 3, 4, 5, 6, 7; and at .5, 1, 1.5 and 2 hrs post Dose 7.

Eligibility Criteria

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Ages Eligible for Study:	2 Years to 12 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Males or females between 2 to ≤12 years of age. Females of child-bearing potential must be practicing abstinence or using a medically acceptable form of contraception (eg, intrauterine device, hormonal birth control, or double barrier method). For the purpose of this study, all peri- and post-pubertal females will be considered to be of child-bearing potential unless they are biologically sterile or surgically sterile for more than 1 year
2. Subjects must be at least 10 kg and BMI ≤30
3. Scheduled to have a surgery for which oral opioid analgesia will be needed to manage postoperative pain for at least 24 hours (Single-Dose Phase) or 48 hours (Multiple-Dose Phase)following intraoperative and/or postoperative parenteral analgesia
4. Be hospital inpatients, expected to be hospitalized for at least 24 hours (Single-Dose Phase) and 48 hours (Multiple-Dose Phase) following the initial administration of oxymorphone immediate release
5. Available lab results, either intraoperatively (prior to surgical incision) or from within 21 days preoperatively, for clinical chemistry and hematology laboratory analytes (the results must have been reviewed by the Investigator for study eligibility)
6. Able to provide pain assessment evaluations using an age-appropriate instrument provided in the protocol
7. On an intravenous analgesic regimen utilizing a short-acting opioid analgesic following surgery AND anticipated to be switched to an oral opioid as part of the analgesic regimen (according to institution SOC)
8. Demonstrated the ability to tolerate clear fluids following surgery according to the SOC at each institution
9. Informed of the nature of the study and written informed consent has been obtained from the legally responsible parent(s)/legal guardian(s)
10. Provided assent in accordance with IRB requirements
11. Line in place for blood sampling

Exclusion Criteria:

1. Known allergies or sensitivities to oxymorphone or other opioid analgesics
2. Known sensitivity to any component of the study drug
3. Life expectancy <4 weeks
4. Positive pregnancy test at screening (females of reproductive age only)
5. Pregnant and/or lactating
6. Cyanotic heart disease
7. Respiratory, hepatic, renal, neurological, psychological disease, or any other clinically significant condition that would, in the Investigator's opinion, preclude participation in the study
8. Preoperative opioids administered for a period of more than 72 hours in duration
9. Abdominal trauma that would interfere with absorption of study drug
10. Increased intracranial pressure
11. Respiratory condition requiring intubation
12. History of uncontrolled seizures that are not being managed with anticonvulsants
13. Significant prior history of substance abuse or alcohol abuse
14. Received any investigational drug within 30 days prior to the first dose of study drug, or are scheduled to receive an investigational drug other than oxymorphone HCl immediate-release oral liquid during the course of the study
15. Received a monoamine oxidase inhibitor (MAOI) within 14 days prior to the start of study drug
16. Received oxycodone or oxymorphone within 48 hours prior to study start
17. Investigator anticipates that the subject and/or parent(s)/legal guardian(s) would be unable to comply with the protocol
18. Subject (and/or parent[s]/legal guardian[s]) is(are) unable to communicate effectively with study personnel at an age-appropriate level

Contacts and Locations

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Locations

United States, Arizona
University of Arizona Medical Center
Tucson, Arizona, United States, 85724
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, Colorado
The Children's Hospital
Aurora, Colorado, United States, 80045
United States, Indiana
Indiana Univeristy School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
United States, Texas
Children's Medical Center Dallas
Dallas, Texas, United States, 75235

Sponsors and Collaborators

Endo Pharmaceuticals

Investigators

Study Director:	Todd Kirby, PhD	Endo Pharmaceuticals

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Endo Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01210352 History of Changes
Other Study ID Numbers:	EN3319-302
First Posted:	September 28, 2010
Last Update Posted:	January 17, 2018
Last Verified:	January 2018

Keywords provided by Endo Pharmaceuticals:

surgical pain; acute pain; Acute Post Surgical Pain

Additional relevant MeSH terms:

Pain, Postoperative; Pain; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Signs and Symptoms; Oxymorphone	Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Adjuvants, Anesthesia