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

NCT ID: NCT01210352

Last Updated: 2021-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-13
• Study Completion Date: 2017-10-06

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 subjects.

This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.

Conditions

Post Operative Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CII Drug

Open Label

Group Type: EXPERIMENTAL

oxymorphone HCl

Intervention Type: DRUG

Comparison of different dosages of drug, 0.05mg/kg, 0.10mg/kg, 0.15mg/kg or 0.20mg/kg oral liquid oxymorphone

Interventions

oxymorphone HCl

Comparison of different dosages of drug, 0.05mg/kg, 0.10mg/kg, 0.15mg/kg or 0.20mg/kg oral liquid oxymorphone

Intervention Type: DRUG

Other Intervention Names

Opana

Eligibility 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 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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endo Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saji Vijayan, MD

Role: STUDY_DIRECTOR

Endo Pharmaceuticals

Locations

Endo Clinical Trial Site #19

Tucson, Arizona, United States

Endo Clinical Trial Site #1

Little Rock, Arkansas, United States

Endo Clinical Trial Site #3

Aurora, Colorado, United States

Endo Clinical Trial Site #6

Indianapolis, Indiana, United States

Endo Clinical Trial Site #11

Oklahoma City, Oklahoma, United States

Endo Clinical Trial Site #12

Pittsburgh, Pennsylvania, United States

Endo Clinical Trial Site #13

Nashville, Tennessee, United States

Endo Clinical Trial Site #14

Dallas, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EN3319-302

Identifier Type: -

Identifier Source: org_study_id