Clinical Study to Evaluate the Effectiveness, Safety, and Tolerability of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects
Condition: Post-Operative Pain; Acute Pain
MeSH terms: Pain, Postoperative; Acute Pain
Intervention: Oxymorphone HCl; Placebo
Intervention description: Oral liquid and injection; dose to be determined by Independent Data Monitoring Committee (IDMC).; Placebo Comparator for the double-blinded, placebo-controlled multiple-dose phase.
Intervention MeSH terms: Oxymorphone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 0 Years
Maximum age: 2 Years
Healthy volunteers: No
Keywords: Surgical Pain; Acute Post-Surgical Pain

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is male or female <2 years of age at the time of surgery.

          2. Must weigh at least 3 kg.

          3. 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.

          4. 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.

          5. The subject's parent or guardian has been informed of the nature of the study and has
             provided written informed consent.

             Postoperative:

          6. 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).

          7. Is an inpatient expected to be hospitalized for 24 hours after dosing with study drug.

          8. Has an indwelling access catheter for blood sampling.

          9. 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.

         10. Prior to administration of oxymorphone HCl oral solution, for Groups A and B, had
             demonstrated the ability to tolerate clear liquids, following surgery according to the
             SOC at each institution. All infants and children should be able to demonstrate strong
             suck and swallow reflexes and neurologic alertness and stability sufficient to handle
             oral secretions. The ability to tolerate small amounts (1 to 2 oz.) of clear liquids
             without emesis (over 30 to 60 minutes) would support readiness for study participation
             and oral intake once the physician has ordered the diet advanced to clear liquids and
             the subject has ingested fluids by mouth without nausea or vomiting.

        Exclusion Criteria:

        Subjects who meet any of the following criteria will not be eligible to participate in the
        study:

          1. 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.

          2. Has any clinical laboratory test result outside the accepted range that has been
             confirmed upon re-examination and deemed to be clinically significant.

          3. Has a clinically significant illness or condition any time before dosing with study
             drug that would contraindicate participation, as determined by the Investigator.

          4. Has a life expectancy <8 weeks.

          5. For age groups A and B: Has a malabsorption, gastroenterologic, or abdominal condition
             that would interfere with the absorption of study drug.

          6. Has evidence of increased intracranial pressure.

          7. 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%.

          8. Has a history of seizures.

          9. 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.

         10. Subject (and/or mother if subject is nursing) has received preoperative opioids for
             more than 72 consecutive hours.

         11. Subject (and/or mother if subject is nursing) has received oxycodone or oxymorphone
             within 48 hours prior to screening.

         12. Subject (and/or mother if subject is nursing) has ingested caffeine- or
             xanthine-containing products (eg, theophylline) within 48 prior to screening. These
             products are also prohibited during periods when blood samples are collected.

         13. Has a history of relevant drug allergies, food allergies, or both (ie, allergy to
             oxymorphone or other opioid analgesics) that could interfere with the study.

         14. Parent or legal guardian is unable to provide consent for any reason (eg, mental or
             physical disabilities, language barriers, or is unavailable).

         15. Subject (and/or mother if subject is nursing) has participated in a clinical study of
             an unapproved drug within the previous 30 days.

         16. Is not suitable for entry into the study in the opinion of the Investigator.