Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Intervention: oxymorphone HCl
Intervention description: Comparison of different dosages of drug, 0.05mg/kg, 0.10mg/kg, 0.15mg/kg or 0.20mg/kg oral liquid oxymorphone
Intervention MeSH terms: Oxymorphone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 0 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: surgical pain; acute pain; Acute Post Surgical Pain

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.

      This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer
      promotes opioids and no longer markets Opana® ER.
    

Eligibility 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