Clinical Study to Evaluate the Effectiveness, Safety, and Tolerability of Oxymorphone Immediate R… (NCT02687451) | Clinical Trial Compass
TerminatedPhase 3
Clinical Study to Evaluate the Effectiveness, Safety, and Tolerability of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects
Stopped: Released from PMR
United States28 participantsStarted 2016-04
Plain-language 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.
Who can participate
Age range0 Years – 2 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Cumulative Total Amount of Morphine Rescue Medication Required for Analgesia in the Active Treatment Group (Single Dose)
Timeframe: Up to 24 hours post dose
2
Cumulative Total Amount of Morphine Rescue Medication Required for Analgesia in the Active Treatment Group Versus Placebo Group (Multiple Dose).
✕. 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%.