AN OPEN-LABEL, NON-RANDOMIZED, MULTICENTER, ASCENDING DOSE BY AGE, SINGLE- AND MULTIPLE-DOSE EVALUATION OF THE EFFECTIVENESS, SAFETY, AND TOLERABILITY OF OXYMORPHONE HCl IMMEDIATE-RELEASE ORAL LIQUID FOR ACUTE POSTOPERATIVE PAIN IN PEDIATRIC SUBJECTS

Study ID
STU 092010-037

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Children's Medical Center-Dallas

Contact
Roxana Ploski
214-456-8559
roxana.ploski@utsouthwestern.edu

Principal Investigator
Peter Szmuk

Summary

This is an open-label, non-randomized, multicenter, ascending dose by age, single- and multipledose
phase study to evaluate the effectiveness, safety, and tolerability of oral liquid
oxymorphone for post-operative pain in pediatric subjects. The oxymorphone HCl immediaterelease
oral liquid dose was chosen based on an established equivalent morphine dose (0.3 mg/kg
by mouth every 3 to 4 hours) in children being treated for acute pain.
The study subjects will be stratified into 2 age groups; the study will enroll using parallel
enrollment with these age groups (spanning ages 2 to [LessThanorequalTo]12 years). These age groups will be
studied in parallel because they have mature pathways for metabolism of opioids.
in both the Single- and Multiple-Dose Phases, as each treatment cohort of subjects within each
age group is completed, the effectiveness, safety, and tolerability will be assessed by the
independent Data Monitoring Committee (iDMC) before enrolling subjects into the next-higher
treatment cohort. upon completion of each treatment cohort (of each age group) during the
Single-Dose Phase, the iDMC will provide recommendation on whether additional cohorts are
needed in the Single-Dose Phase (up to 3 treatment cohorts in total may be tested in the
Single-Dose Phase for each age group). as each age group completes the Single-Dose Phase, the
iDMC will assess the data based on the effectiveness, safety, and tolerability of the study drug
and will provide recommendations for the doses to be used in the age group's Multiple-Dose
Phase. up to 3 treatment cohorts (ie, doses) of subjects may be tested in the Multiple-Dose Phase
for each age group.

Participant Eligibility

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
post-operative 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 prior to study drug administration 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