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

Condition(s) targeted: Post Operative Pain

Intervention: oxymorphone HCl (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Endo Pharmaceuticals

Official(s) and/or principal investigator(s):
Carla Chieffo, PhD, Study Director, Affiliation: Endo Pharmaceuticals

Overall contact:
Doris Schmidt, Phone: 610-459-7434, Email: Schmidt.DorisAnn@Endo.com

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.

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Assessment of safety and tolerability will be based on the incidence of Adverse Events(AEs), AEs resulting in discontinuation and serious adverse events

Secondary outcome: To determine and report the the pharmacokinetic profile of oxymorphone IR oral liquid in pediatric subjects in order to determine appropriate dosing recommendations.

Minimum age: 2 Years. Maximum age: 12 Years. Gender(s): Both.

Criteria:

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

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

Doris Schmidt, Phone: 610-459-7434, Email: Schmidt.DorisAnn@Endo.com

Phoenix Children's Hospital, Phoenix, Arizona 85023, United States; Not yet recruiting
John Jones, MD, Principal Investigator

University of Arizona Medical Center, Tucson, Arizona 85724, United States; Recruiting
Wallace Nogami, Principal Investigator

Arkansas Children's Hospital, Little Rock, Arkansas 72202, United States; Terminated

Loma Linda University Children's Hospital, Loma Linda, California 92350, United States; Withdrawn

Stanford University, Stanford, California 94305-5640, United States; Withdrawn

The Children's Hospital, Aurora, Colorado 80045, United States; Recruiting
Jeffery Galinkin, MD, Principal Investigator

Children's National Medical Center, Washington, District of Columbia 20010, United States; Withdrawn

Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia 30322, United States; Not yet recruiting
Carolyn Bannister, MD, Principal Investigator

Indiana Univeristy School of Medicine, Indianapolis, Indiana 46202, United States; Terminated

University of Louisville, Louisville, Kentucky 40202, United States; Recruiting
Janice Sullivan, Principal Investigator

Johns Hopkins University School of Medicine, Baltimore, Maryland 21287, United States; Recruiting
Constance Monitto, MD, Principal Investigator

Duke University Medical Center, Durham, North Carolina 27710, United States; Withdrawn

Akron Children's Hospital, Akron, Ohio 44308, United States; Withdrawn

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73104, United States; Not yet recruiting
Alberto de Armendi, MD, Principal Investigator

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15224, United States; Recruiting
Mihaela Visoiu, MD, Principal Investigator

Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville, Tennessee 37232, United States; Recruiting
Stephen Hays, MD, Principal Investigator

Children's Medical Center Dallas, Dallas, Texas 75235, United States; Recruiting
Peter Szmuk, Principal Investigator

Texas Tech University Health Sciences Center, Lubbock, Texas 79430, United States; Withdrawn

Harborview Medical Center, Seattle, Washington 98104, United States; Recruiting
Sanjay Bhananker, MD, Principal Investigator

Starting date: December 2010
Last updated: January 8, 2013