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

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ClinicalTrials.gov Identifier: NCT02687451
Recruitment Status : Suspended (Awaiting FDA feedback)
First Posted : February 22, 2016
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Post-Operative Pain Acute Pain Drug: Oxymorphone HCl Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oxymorphone HCl Open-Label Phase
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
Drug: Oxymorphone HCl
Oral liquid and injection; dose to be determined by Independent Data Monitoring Committee (IDMC).
Other Name: Opana

Experimental: Oxymorphone HCl Multiple-Dose Phase
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; placebo controlled, randomized, double-blinded multiple-dose phase.
Drug: Oxymorphone HCl
Oral liquid and injection; dose to be determined by Independent Data Monitoring Committee (IDMC).
Other Name: Opana

Placebo Comparator: Placebo
Sodium Chloride 0.9% solution; comparator for multiple-dose phase.
Drug: Placebo
Placebo Comparator for the double-blinded, placebo-controlled multiple-dose phase.




Primary Outcome Measures :
  1. Cumulative total amount of morphine rescue medication required for analgesia in the active treatment group versus placebo group. [ Time Frame: Up to 24 hours post dose ]

Secondary Outcome Measures :
  1. Safety will be measured by incidence of Abnormal Laboratory Values, Vital Sign Values, and/or Adverse Events that are related to treatment. [ Time Frame: Up to 24 hours post dose ]
  2. Assessment of pain using the age appropriate scale, Face, Legs, Activity, Cry, Consolability (FLACC) or the Neonatal Infant Pain Scale (NIPS). [ Time Frame: 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. ]
    The FLACC will be used for patients between the ages of 6 months and 2 years. The NIPS will be used for patients 0 to < 6 months.

  3. Pharmacokinetic variable: Volume of Distribution (Vd) [ Time Frame: Up to 24 hours post dose ]
  4. Pharmacokinetic variable: Clearance (CL) [ Time Frame: Up to 24 hours post dose ]


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687451


Locations
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United States, North Carolina
Endo Clinical Trial Site #2
Durham, North Carolina, United States, 27710
United States, Texas
Endo Clinical Trial Site #1
Dallas, Texas, United States, 75235
Endo Clinical Trial Site #4
Houston, Texas, United States, 77030
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
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Study Director: Shannon Dalton Endo Pharmceuticals

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Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02687451     History of Changes
Other Study ID Numbers: EN3319-304
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Keywords provided by Endo Pharmaceuticals:
Surgical Pain
Acute Post-Surgical Pain
Additional relevant MeSH terms:
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Pain, Postoperative
Acute Pain
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
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