Status:
COMPLETED
Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Post Operative Pain
Eligibility:
All Genders
Up to 12 years
Phase:
PHASE3
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 subject...
Eligibility Criteria
Inclusion
- 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
- Subjects must be at least 10 kg and BMI ≤30
- 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
- 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
- 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)
- Able to provide pain assessment evaluations using an age-appropriate instrument provided in the protocol
- 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)
- Demonstrated the ability to tolerate clear fluids following surgery according to the SOC at each institution
- Informed of the nature of the study and written informed consent has been obtained from the legally responsible parent(s)/legal guardian(s)
- Provided assent in accordance with IRB requirements
- Line in place for blood sampling
Exclusion
- Known allergies or sensitivities to oxymorphone or other opioid analgesics
- Known sensitivity to any component of the study drug
- Life expectancy \<4 weeks
- Positive pregnancy test at screening (females of reproductive age only)
- Pregnant and/or lactating
- Cyanotic heart disease
- Respiratory, hepatic, renal, neurological, psychological disease, or any other clinically significant condition that would, in the Investigator's opinion, preclude participation in the study
- Preoperative opioids administered for a period of more than 72 hours in duration
- Abdominal trauma that would interfere with absorption of study drug
- Increased intracranial pressure
- Respiratory condition requiring intubation
- History of uncontrolled seizures that are not being managed with anticonvulsants
- Significant prior history of substance abuse or alcohol abuse
- 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
- Received a monoamine oxidase inhibitor (MAOI) within 14 days prior to the start of study drug
- Received oxycodone or oxymorphone within 48 hours prior to study start
- Investigator anticipates that the subject and/or parent(s)/legal guardian(s) would be unable to comply with the protocol
- Subject (and/or parent\[s\]/legal guardian\[s\]) is(are) unable to communicate effectively with study personnel at an age-appropriate level
Key Trial Info
Start Date :
December 13 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2017
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT01210352
Start Date
December 13 2010
End Date
October 6 2017
Last Update
August 20 2021
Active Locations (8)
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1
Endo Clinical Trial Site #19
Tucson, Arizona, United States, 85724
2
Endo Clinical Trial Site #1
Little Rock, Arkansas, United States, 72202
3
Endo Clinical Trial Site #3
Aurora, Colorado, United States, 80045
4
Endo Clinical Trial Site #6
Indianapolis, Indiana, United States, 46202