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

Study ID
EN3319-302

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Children’s Medical Center (Dallas, Plano, Southlake)

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

Principal Investigator
Peter Szmuk

Official Title

An Open-Label, Non-randomized, Multicenter, Ascending Dose by Age, Single- and Multiple-Dose Evaluation of the Effectiveness, Safety, and Tolerability of Oral Liquid Oxymorphone HCl Immediate-Release Oral Liquid for Acute Postoperative Pain in Pediatric Subjects

Brief Overview


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 subjects.

Participant Eligibility


Inclusion Criteria:

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
postoperative 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 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

Exclusion Criteria:

1. Known allergies or sensitivities to oxymorphone or other opioid analgesics

2. Known sensitivity to any component of the study drug

3. Life expectancy <4 weeks

4. Positive pregnancy test at screening (females of reproductive age only)

5. Pregnant and/or lactating

6. Cyanotic heart disease

7. Respiratory, hepatic, renal, neurological, psychological disease, or any other
clinically significant condition that would, in the Investigator's opinion, preclude
participation in the study

8. Preoperative opioids administered for a period of more than 72 hours in duration

9. Abdominal trauma that would interfere with absorption of study drug

10. Increased intracranial pressure

11. Respiratory condition requiring intubation

12. History of uncontrolled seizures that are not being managed with anticonvulsants

13. Significant prior history of substance abuse or alcohol abuse

14. 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

15. Received a monoamine oxidase inhibitor (MAOI) within 14 days prior to the start of
study drug

16. Received oxycodone or oxymorphone within 48 hours prior to study start

17. Investigator anticipates that the subject and/or parent(s)/legal guardian(s) would be
unable to comply with the protocol

18. Subject (and/or parent[s]/legal guardian[s]) is(are) unable to communicate
effectively with study personnel at an age-appropriate level