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

NCT01210352 | Completed Phase 3 Results DMC

• 1 other identifier: EN3319-302
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 8

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

Keywords

surgical pain; acute pain; Acute Post Surgical Pain

Outcome Measures

Primary Outcomes (5)

• Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase

  Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain). Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 years and 0 years to \< 2 years age groups, (0 = no pain and 10 = very much pain).

  Baseline, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose; and at the time of rescue

• Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase

  Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain). Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 years and 0 years to \< 2 years age groups, (0 = no pain and 10 = very much pain). PID was calculated as the pain intensity score at baseline minus the current pain intensity score at each corresponding time point.

  Baseline (prior to dose); 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose; and at the time of rescue

• Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase

  Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain). Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 years and 0 years to \< 2 years age groups, (0 = no pain and 10 = very much pain)

  Baseline, 0.5, 1, 1.5, 2, hours post dose, and immediately prior to all remaining doses administered through 48 hours after administration of the initial dose; and at time of rescue

• Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase

  Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain). Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 years and 0 years to \< 2 years age groups, (0 = no pain and 10 = very much pain). PID is calculated as the pain intensity score at baseline minus the current pain intensity score at each corresponding time point.

  0.5, 1, 1.5, 2, hours post dose 1 through to Dose 12, 0 Hour; End of Study/Early Termination

• Number (%) of Subjects With Rescue Medication Use by Age and Dose Group in Multiple-Dose Phase

  Rescue Medication Use in Multiple Dose Phase

  Rescue Medication Use

Secondary Outcomes (36)

• Oxymorphone Cmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase

  Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

• Oxymorphone Tmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase

  Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

• Oxymorphone Clast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase

  Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

• Oxymorphone Tlast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase

  Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

• Oxymorphone AUC0-t Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase

  Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Study Arms (1)

CII Drug

EXPERIMENTAL

Open Label

Drug: oxymorphone HCl

Interventions

oxymorphone HCl DRUG

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

Also known as: Opana

CII Drug

Eligibility Criteria

• Age: 0 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (8)

Endo Clinical Trial Site #19

Tucson, Arizona, 85724, United States

Location

Endo Clinical Trial Site #1

Little Rock, Arkansas, 72202, United States

Location

Endo Clinical Trial Site #3

Aurora, Colorado, 80045, United States

Location

Endo Clinical Trial Site #6

Indianapolis, Indiana, 46202, United States

Location

Endo Clinical Trial Site #11

Oklahoma City, Oklahoma, 73104, United States

Location

Endo Clinical Trial Site #12

Pittsburgh, Pennsylvania, 15224, United States

Location

Endo Clinical Trial Site #13

Nashville, Tennessee, 37232, United States

Location

Endo Clinical Trial Site #14

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain

Interventions

Oxymorphone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

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

Results Point of Contact

• Title: Saji Vijayan
• Organization: Endo Pharmaceuticals

ClinicalTrials@Endo.com

(800) 462-3636

Study Officials

• Saji Vijayan, MD

  Endo Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2010
• First Posted: September 28, 2010
• Study Start: December 13, 2010
• Primary Completion: October 6, 2017
• Study Completion: October 6, 2017
• Last Updated: August 20, 2021
• Results First Posted: May 7, 2019

Record last verified: 2019-05

Locations

US (8)