Effectiveness, Safety, and Tolerability Study of Oxymorph... | NCT01210352 | Trialant
NCT01210352
Sponsor
Endo USA Inc., a Keenova Therapeutics Company
Status
Completed
Last Update Posted
Aug 20, 2021Actual
Enrollment
61Actual
Phase
Phase 3
Conditions
Post Operative Pain
Interventions
oxymorphone HCl
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT01210352
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
EN3319-302
Secondary IDs
Not provided
Brief Title
Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical 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
Acronym
Not provided
Organization
Endo USA Inc., a Keenova Therapeutics CompanyINDUSTRY
Status Module
Record Verification Date
May 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 13, 2010Actual
Primary Completion Date
Oct 6, 2017Actual
Completion Date
Oct 6, 2017Actual
First Submitted Date
Sep 17, 2010
First Submission Date that Met QC Criteria
Sep 27, 2010
First Posted Date
Sep 28, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 20, 2018
Results First Submitted that Met QC Criteria
May 6, 2019
Results First Posted Date
May 7, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 18, 2021
Last Update Posted Date
Aug 20, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Endo USA Inc., a Keenova Therapeutics CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Post Operative Pain
Keywords
surgical pain
acute pain
Acute Post Surgical Pain
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
61Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
CII Drug
Experimental
Open Label
Drug: oxymorphone HCl
Interventions
Name
Type
Description
Arm Group Labels
Other Names
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
CII Drug
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
Secondary Outcomes
Measure
Description
Time Frame
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
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
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
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Received oxycodone or oxymorphone within 48 hours prior to study start
Investigator anticipates that the subject and/or parent(s)/legal guardian(s) would be unable to comply with the protocol
Subject (and/or parent[s]/legal guardian[s]) is(are) unable to communicate effectively with study personnel at an age-appropriate level
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
0 Years
Maximum Age
12 Years
Standard Ages
Child
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Saji Vijayan, MD
Endo USA Inc., a Keenova Therapeutics Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Endo Clinical Trial Site #19
Tucson
Arizona
85724
United States
Endo Clinical Trial Site #1
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Single Dose Phase 6 to ≤12 Years Age Group: 0.05 mg/kg
6 to ≤12 year age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid
FG001
Single-Dose Phase 6 to ≤12 Years Age Group: 0.10 mg/kg
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
1
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Aug 21, 2013
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Opana
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
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
Tmax: The time at which Cmax was observed
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
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
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
Tlast: The time at which Clast was observed
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
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
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-inf 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
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
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 AUC0-24 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
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
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 t1/2 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
t1/2: Terminal half-life, calculated as λn/(ln 2)
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
Dose-Normalized Oxymorphone CL/F 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
CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf
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
Dose-Normalized Oxymorphone V/F 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
V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf * λn)
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 Cmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
Oxymorphone Tmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Tmax: The time at which Cmax was observed
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
Oxymorphone Clast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
Oxymorphone Tlast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Tlast: The time at which Clast was observed
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
Oxymorphone AUC0-t Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
Oxymorphone AUC0-inf Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
Oxymorphone AUC0-24 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
Oxymorphone t1/2 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
t1/2: Terminal half-life, calculated as λn/(ln 2)
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
6 Beta-Hydroxyoxymorphone 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
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
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
6 Beta-Hydroxyoxymorphone 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
Tmax: The time at which Cmax was observed
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
6 Beta-Hydroxyoxymorphone 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
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
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
6 Beta-Hydroxyoxymorphone 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
Tlast: The time at which Clast was observed
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
6 Beta-Hydroxyoxymorphone 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
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
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
6 Beta-Hydroxyoxymorphone AUC0-inf 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
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
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
6 Beta-Hydroxyoxymorphone AUC0-24 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
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
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
6 Beta-Hydroxyoxymorphone t1/2 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
t1/2: Terminal half-life, calculated as λn/(ln 2)
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
Dose-Normalized 6 Beta-Hydroxyoxymorphone CL/F 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
CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf
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
Dose-Normalized 6 Beta-Hydroxyoxymorphone V/F 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
V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf * λn)
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
6 Beta-Hydroxyoxymorphone Cmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
6 Beta-Hydroxyoxymorphone Tmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Tmax: The time at which Cmax was observed
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
6 Beta-Hydroxyoxymorphone Clast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
6 Beta-Hydroxyoxymorphone Tlast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Tlast: The time at which Clast was observed
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
6 Beta-Hydroxyoxymorphone AUC0-t Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
6 Beta-Hydroxyoxymorphone AUC0-inf Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
6 Beta-Hydroxyoxymorphone AUC0-24 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
6 Beta-Hydroxyoxymorphone t1/2 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
t1/2: Terminal half-life, calculated as λn/(ln 2)
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
Little Rock
Arkansas
72202
United States
Endo Clinical Trial Site #3
Aurora
Colorado
80045
United States
Endo Clinical Trial Site #6
Indianapolis
Indiana
46202
United States
Endo Clinical Trial Site #11
Oklahoma City
Oklahoma
73104
United States
Endo Clinical Trial Site #12
Pittsburgh
Pennsylvania
15224
United States
Endo Clinical Trial Site #13
Nashville
Tennessee
37232
United States
Endo Clinical Trial Site #14
Dallas
Texas
75235
United States
6 to ≤12 year age group in the Single Dose Phase given 0.10 mg/kg oxymorphone HCl IR oral liquid
FG002
Single Dose Phase 6 to ≤12 Years Age Group: 0.20 mg/kg
6 to ≤12 year age group in the Single Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid
FG003
Single Dose Phase 2 to <6 Years Age Group: 0.05 mg/kg
2 to <6 Years age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid
FG004
Single Dose Phase 2 to <6 Years Age Group: 0.10 mg/kg
2 to <6 Years age group in the Single Dose Phase given 0.10 mg/kg oxymorphone HCl IR oral liquid
FG005
Single Dose Phase 2 to <6 Years Age Group: 0.20 mg/kg
2 to <6 Years age group in the Single Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid
FG006
Single Dose Phase 0 to < 2 Years Age Group: 0.05 mg/kg
0 to < 2 Years age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid
FG007
Multiple Dose Phase 6 to ≤12 Years Age Group: 0.20 mg/kg
6 to ≤12 year age group in the Multiple Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid
FG008
Multiple Dose Phase 2 to <6 Years Age Group: 0.20 mg/kg
2 to <6 year age group in the Multiple Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid
FG0006 subjects
FG0016 subjects
FG0027 subjects
FG0037 subjects
FG0046 subjects
FG0056 subjects
FG0067 subjects
FG00710 subjects
FG0086 subjects
COMPLETED
FG0006 subjects
FG0016 subjects
FG0025 subjects
FG0037 subjects
FG0046 subjects
FG0056 subjects
FG0065 subjects
FG0077 subjects
FG0082 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
FG0073 subjects
FG0084 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0081 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Patient Discharged Early
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Single Dose Phase 6 to ≤12 Years Age Group: 0.05 mg/kg
6 to ≤12 year age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid
BG001
Single-Dose Phase 6 to ≤12 Years Age Group: 0.10 mg/kg
6 to ≤12 year age group in the Single Dose Phase given 0.10 mg/kg oxymorphone HCl IR oral liquid
BG002
Single Dose Phase 6 to ≤12 Years Age Group: 0.20 mg/kg
6 to ≤12 year age group in the Single Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid
BG003
Single Dose Phase 2 to <6 Years Age Group: 0.05 mg/kg
2 to <6 Years age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid
BG004
Single Dose Phase 2 to <6 Years Age Group: 0.10 mg/kg
2 to <6 Years age group in the Single Dose Phase given 0.10 mg/kg oxymorphone HCl IR oral liquid
BG005
Single Dose Phase 2 to <6 Years Age Group: 0.20 mg/kg
2 to <6 Years age group in the Single Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid
BG006
Single Dose Phase 0 to < 2 Years Age Group: 0.05 mg/kg
0 to < 2 Years age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid
BG007
Multiple Dose Phase 6 to ≤12 Years Age Group: 0.20 mg/kg
6 to ≤12 year age group in the Multiple Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid
BG008
Multiple Dose Phase 2 to <6 Years Age Group: 0.20 mg/kg
2 to <6 year age group in the Multiple Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG0016
BG0027
BG0037
BG0046
BG0056
BG0067
BG00710
BG0086
BG00961
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG0008.3± 1.75
BG0018.7± 1.86
BG0029.0± 2.16
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Weight
Mean
Standard Deviation
kg
Title
Denominators
Categories
Title
Measurements
BG00035.25± 11.725
BG00130.33± 17.731
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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).
Effectiveness Population. The analyses performed for this study report did not differentiate the pain intensity and pain intensity difference by age/dose combination.
The analyses were conducted by age group alone and results are presented accordingly.
Posted
Mean
Standard Deviation
score on a scale
Baseline, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose; and at the time of rescue
ID
Title
Description
OG000
6 Years to ≤ 12 Years Age Group in Single Dose Phase
Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group
OG001
2 Years to < 6 Years Age Group in Single Dose Phase
Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to < 6 year age group
OG002
0 Years to < 2 Years Age Group in Single Dose Phase
Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to < 2 years age group
Units
Counts
Participants
OG00019
OG00119
OG0027
Title
Denominators
Categories
Baseline (Prior to Treatment)
ParticipantsOG00019
ParticipantsOG00119
ParticipantsOG0027
Title
Measurements
Primary
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.
Effectiveness Population. The analyses performed for this study report did not differentiate the pain intensity and pain intensity difference by age/dose combination.
The analyses were conducted by age group alone and results are presented accordingly.
Posted
Mean
Standard Deviation
score on a scale
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
ID
Title
Description
OG000
6 Years to ≤ 12 Years Age Group in Single Dose Phase
Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group
OG001
2 Years to < 6 Years Age Group in Single Dose Phase
Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to < 6 year age group
OG002
Primary
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)
Effectiveness Population. Based on the recommendation of the Independent Data Monitoring Committee (IDMC), there was only 1 dose group of 0.2 mg/kg administered during the Multiple-dose Phase. Thus, this outcome measure was only assessed in this dose group.
Posted
Mean
Standard Deviation
score on a scale
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
ID
Title
Description
OG000
6 Years to ≤ 12 Years Age Group in Multiple Dose Phase
Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group
OG001
2 Years to < 6 Years Age Group in Multiple Dose Phase
Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to < 6 year age group
Primary
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.
Effectiveness Population.IDMC recommended dose: 0.20 mg/kg oxymorphone HCl oral solution for the Multiple-dose Phase. Therefore, the analyses were conducted in a total of 16 subjects ranging from 2 to ≤12 years who received the dose of 0.20 mg/kg oxymorphone HCl oral solution as shown in the table of baseline characteristic in the participant flow.
Posted
Mean
Standard Deviation
score on a scale
0.5, 1, 1.5, 2, hours post dose 1 through to Dose 12, 0 Hour; End of Study/Early Termination
ID
Title
Description
OG000
6 to ≤12 Years Age Group: 0.20 mg/kg
Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group
OG001
2 to <6 Years Age Group: 0.20 mg/kg
Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to < 6 year age group
Primary
Number (%) of Subjects With Rescue Medication Use by Age and Dose Group in Multiple-Dose Phase
Rescue Medication Use in Multiple Dose Phase
Effectiveness Population.IDMC recommended dose: 0.20 mg/kg oxymorphone HCl oral solution for the Multiple-dose Phase. Therefore, the analyses were conducted in a total of 16 subjects ranging from 2 to ≤12 years who received the dose of 0.20 mg/kg oxymorphone HCl oral solution as shown in the table of baseline characteristic in the participant flow.
Posted
Count of Participants
Participants
Rescue Medication Use
ID
Title
Description
OG000
6 to ≤12 Years Age Group: 0.20 mg/kg
Percentages are based on the number of subjects ('N') in effectiveness population in each dose group in each age group in Multiple-Dose Phase
OG001
2 to <6 Years Age Group: 0.20 mg/kg
Percentages are based on the number of subjects ('N') in effectiveness population in each dose group in each age group in Multiple-Dose Phase
Units
Counts
Participants
Secondary
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
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Posted
Mean
Standard Deviation
ng/mL
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
ID
Title
Description
OG000
0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
OG001
0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
OG002
0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
OG003
Secondary
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
Tmax: The time at which Cmax was observed
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Posted
Mean
Standard Deviation
h
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
ID
Title
Description
OG000
0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
Tmax: The time at which Cmax was observed
OG001
0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Tmax: The time at which Cmax was observed
OG002
0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
Tmax: The time at which Cmax was observed
OG003
0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Tmax: The time at which Cmax was observed
Secondary
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
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Posted
Mean
Standard Deviation
ng/mL
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
ID
Title
Description
OG000
0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
OG001
0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
OG002
0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
OG003
Secondary
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
Tlast: The time at which Clast was observed
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Posted
Mean
Standard Deviation
h
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
ID
Title
Description
OG000
0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
Tlast: The time at which Clast was observed
OG001
0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Tlast: The time at which Clast was observed
OG002
0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
Tlast: The time at which Clast was observed
OG003
0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Secondary
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
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Posted
Mean
Standard Deviation
h*ng/mL
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
ID
Title
Description
OG000
0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
OG001
0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
OG002
0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
Secondary
Oxymorphone AUC0-inf 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
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Posted
Mean
Standard Deviation
h*ng/mL
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
ID
Title
Description
OG000
0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
OG001
0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
OG002
0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
Secondary
Oxymorphone AUC0-24 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
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Posted
Mean
Standard Deviation
h*ng/mL
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
ID
Title
Description
OG000
0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
OG001
0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
OG002
0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
Secondary
Oxymorphone t1/2 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
t1/2: Terminal half-life, calculated as λn/(ln 2)
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Posted
Mean
Standard Deviation
h
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
ID
Title
Description
OG000
0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
t1/2: Terminal half-life, calculated as λn/(ln 2)
OG001
0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
t1/2: Terminal half-life, calculated as λn/(ln 2)
OG002
0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
t1/2: Terminal half-life, calculated as λn/(ln 2)
OG003
0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Secondary
Dose-Normalized Oxymorphone CL/F 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
CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf
PK Population (subjects with sufficient plasma concentration data to calculate PK parameter values). Since the overall exposure (AUC 0 to t) increased in near dose proportional manner, PK parameter values were dose normalized across all dose levels for each age group to determine the CL/F.
Posted
Mean
Standard Deviation
L/h/kg
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
ID
Title
Description
OG000
Combined 0.05, 0.1, and 0.2 mg/kg - Aged 6 Years to ≤ 12 Years
CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf
OG001
Combined 0.05, 0.1, and 0.2 mg/kg - Aged 2 Years to <6 Years
CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf
Units
Counts
Participants
Secondary
Dose-Normalized Oxymorphone V/F 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
V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf * λn)
PK Population (subjects with sufficient plasma concentration data to calculate PK parameter values). Since the overall exposure (AUC 0 to t) increased in near dose proportional manner, PK parameter values were dose normalized across all dose levels for each age group to determine the V/F.
Posted
Mean
Standard Deviation
L/kg
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
ID
Title
Description
OG000
Combined 0.05, 0.1, and 0.2 mg/kg - Aged 6 Years to ≤ 12 Years
V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf * λn)
OG001
Combined 0.05, 0.1, and 0.2 mg/kg - Aged 2 Years to <6 Years
V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf * λn)
Units
Counts
Participants
Secondary
Oxymorphone Cmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Cmax was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.
Posted
Mean
Standard Deviation
ng/mL
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
ID
Title
Description
OG000
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
OG001
0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
OG002
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7
Secondary
Oxymorphone Tmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Tmax: The time at which Cmax was observed
Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Tmax was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.
Posted
Mean
Standard Deviation
h
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
ID
Title
Description
OG000
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1
Tmax: The time at which Cmax was observed
OG001
0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1
Tmax: The time at which Cmax was observed
OG002
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7
Tmax: The time at which Cmax was observed
Secondary
Oxymorphone Clast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Clast was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.
Posted
Mean
Standard Deviation
ng/mL
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
ID
Title
Description
OG000
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
OG001
0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
OG002
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7
Secondary
Oxymorphone Tlast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Tlast: The time at which Clast was observed
Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Tlast was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.
Posted
Mean
Standard Deviation
h
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
ID
Title
Description
OG000
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1
Tlast: The time at which Clast was observed
OG001
0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1
Tlast: The time at which Clast was observed
OG002
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7
Tlast: The time at which Clast was observed
Secondary
Oxymorphone AUC0-t Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of AUC0-t was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.
Posted
Mean
Standard Deviation
h*ng/mL
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
ID
Title
Description
OG000
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
OG001
0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
Secondary
Oxymorphone AUC0-inf Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Posted
Mean
Standard Deviation
h*ng/mL
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
ID
Title
Description
OG000
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
OG001
0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
OG002
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
Secondary
Oxymorphone AUC0-24 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Posted
Mean
Standard Deviation
h*ng/mL
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
ID
Title
Description
OG000
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
OG001
0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
OG002
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
Secondary
Oxymorphone t1/2 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
t1/2: Terminal half-life, calculated as λn/(ln 2)
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Posted
Mean
Standard Deviation
h
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
ID
Title
Description
OG000
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1
t1/2: Terminal half-life, calculated as λn/(ln 2)
OG001
0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1
t1/2: Terminal half-life, calculated as λn/(ln 2)
OG002
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7
t1/2: Terminal half-life, calculated as λn/(ln 2)
OG003
0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Secondary
6 Beta-Hydroxyoxymorphone 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
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Posted
Mean
Standard Deviation
ng/mL
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
ID
Title
Description
OG000
0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
OG001
0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
OG002
0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Secondary
6 Beta-Hydroxyoxymorphone 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
Tmax: The time at which Cmax was observed
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Posted
Mean
Standard Deviation
h
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
ID
Title
Description
OG000
0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
Tmax: The time at which Cmax was observed
OG001
0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Tmax: The time at which Cmax was observed
OG002
0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
Tmax: The time at which Cmax was observed
OG003
0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Secondary
6 Beta-Hydroxyoxymorphone 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
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Posted
Mean
Standard Deviation
ng/mL
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
ID
Title
Description
OG000
0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
OG001
0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
OG002
0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
OG003
Secondary
6 Beta-Hydroxyoxymorphone 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
Tlast: The time at which Clast was observed
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Posted
Mean
Standard Deviation
h
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
ID
Title
Description
OG000
0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
Tlast: The time at which Clast was observed
OG001
0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Tlast: The time at which Clast was observed
OG002
0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
Tlast: The time at which Clast was observed
OG003
0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Secondary
6 Beta-Hydroxyoxymorphone 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
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Posted
Mean
Standard Deviation
h*ng/mL
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
ID
Title
Description
OG000
0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
OG001
0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
OG002
0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
Secondary
6 Beta-Hydroxyoxymorphone AUC0-inf 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
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Posted
Mean
Standard Deviation
h*ng/mL
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
ID
Title
Description
OG000
0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
OG001
0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
OG002
0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
Secondary
6 Beta-Hydroxyoxymorphone AUC0-24 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
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Posted
Mean
Standard Deviation
h*ng/mL
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
ID
Title
Description
OG000
0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
OG001
0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
OG002
0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
Secondary
6 Beta-Hydroxyoxymorphone t1/2 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
t1/2: Terminal half-life, calculated as λn/(ln 2)
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Posted
Mean
Standard Deviation
h
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
ID
Title
Description
OG000
0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
t1/2: Terminal half-life, calculated as λn/(ln 2)
OG001
0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
t1/2: Terminal half-life, calculated as λn/(ln 2)
OG002
0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose
t1/2: Terminal half-life, calculated as λn/(ln 2)
OG003
0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Secondary
Dose-Normalized 6 Beta-Hydroxyoxymorphone CL/F 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
CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf
PK Population (subjects with sufficient plasma concentration data to calculate PK parameter values). Since the overall exposure (AUC 0 to t) increased in near dose proportional manner, PK parameter values were dose normalized across all dose levels for each age group to determine the CL/F.
Posted
Mean
Standard Deviation
L/h/kg
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
ID
Title
Description
OG000
Combined 0.05, 0.1, and 0.2 mg/kg - Aged 6 Years to ≤ 12 Years
CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf
OG001
Combined 0.05, 0.1, and 0.2 mg/kg - Aged 2 Years to <6 Years
CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf
Units
Counts
Participants
Secondary
Dose-Normalized 6 Beta-Hydroxyoxymorphone V/F 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
V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf * λn)
PK Population (subjects with sufficient plasma concentration data to calculate PK parameter values). Since the overall exposure (AUC 0 to t) increased in near dose proportional manner, PK parameter values were dose normalized across all dose levels for each age group to determine the V/F.
Posted
Mean
Standard Deviation
L/kg
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
ID
Title
Description
OG000
Combined 0.05, 0.1, and 0.2 mg/kg - Aged 6 Years to ≤ 12 Years
V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf * λn)
OG001
Combined 0.05, 0.1, and 0.2 mg/kg - Aged 2 Years to <6 Years
V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf * λn)
Units
Counts
Participants
Secondary
6 Beta-Hydroxyoxymorphone Cmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Cmax was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.
Posted
Mean
Standard Deviation
ng/mL
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
ID
Title
Description
OG000
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
OG001
0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
OG002
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7
Secondary
6 Beta-Hydroxyoxymorphone Tmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Tmax: The time at which Cmax was observed
Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Tmax was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.
Posted
Mean
Standard Deviation
h
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
ID
Title
Description
OG000
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1
Tmax: The time at which Cmax was observed
OG001
0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1
Tmax: The time at which Cmax was observed
OG002
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7
Tmax: The time at which Cmax was observed
Secondary
6 Beta-Hydroxyoxymorphone Clast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Clast was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.
Posted
Mean
Standard Deviation
ng/mL
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
ID
Title
Description
OG000
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
OG001
0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
OG002
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7
Secondary
6 Beta-Hydroxyoxymorphone Tlast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Tlast: The time at which Clast was observed
Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Tlast was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.
Posted
Mean
Standard Deviation
h
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
ID
Title
Description
OG000
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1
Tlast: The time at which Clast was observed
OG001
0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1
Tlast: The time at which Clast was observed
OG002
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7
Tlast: The time at which Clast was observed
Secondary
6 Beta-Hydroxyoxymorphone AUC0-t Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of AUC0-t was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.
Posted
Mean
Standard Deviation
h*ng/mL
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
ID
Title
Description
OG000
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
OG001
0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
Secondary
6 Beta-Hydroxyoxymorphone AUC0-inf Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Posted
Mean
Standard Deviation
h*ng/mL
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
ID
Title
Description
OG000
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
OG001
0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
OG002
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
Secondary
6 Beta-Hydroxyoxymorphone AUC0-24 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Posted
Mean
Standard Deviation
h*ng/mL
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
ID
Title
Description
OG000
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
OG001
0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
OG002
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
Secondary
6 Beta-Hydroxyoxymorphone t1/2 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
t1/2: Terminal half-life, calculated as λn/(ln 2)
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Posted
Mean
Standard Deviation
h
Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
ID
Title
Description
OG000
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1
t1/2: Terminal half-life, calculated as λn/(ln 2)
OG001
0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1
t1/2: Terminal half-life, calculated as λn/(ln 2)
OG002
0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7
t1/2: Terminal half-life, calculated as λn/(ln 2)
OG003
0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Time Frame
All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study.
Description
AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
6 Years to ≤ 12 Years Age Group: Single Dose 0.05 mg/kg
All (serious and nonserious) AEs for the 6 years to ≤ 12 years Age Group - Single Dose 0.05 mg/kg
0
6
0
6
5
6
EG001
6 Years to ≤ 12 Years Age Group: Single Dose 0.10 mg/kg
All (serious and nonserious) AEs for the 6 years to ≤ 12 years Age Group - Single Dose 0.10 mg/kg
0
6
1
6
4
6
EG002
6 Years to ≤ 12 Years Age Group: Single Dose 0.20 mg/kg
All (serious and nonserious) AEs for the 6 years to ≤ 12 years Age Group - Single Dose 0.20 mg/kg
0
7
0
7
4
7
EG003
2 Years to < 6 Years Age Group: Single Dose 0.05 mg/kg
All (serious and nonserious) AEs for the 2 years to < 6 years Age Group - Single Dose 0.05 mg/kg
0
7
1
7
7
7
EG004
2 Years to < 6 Years Age Group: Single Dose 0.10 mg/kg
All (serious and nonserious) AEs for the 2 years to < 6 years Age Group - Single Dose 0.10 mg/kg
0
6
0
6
5
6
EG005
2 Years to < 6 Years Age Group: Single Dose 0.20 mg/kg
All (serious and nonserious) AEs for the 2 years to < 6 years Age Group - Single Dose 0.20 mg/kg
0
6
0
6
3
6
EG006
0 to < 2 Years Age Group: Single Dose 0.05 mg/kg
All (serious and nonserious) AEs for the 0 to < 2 years Age Group - Single Dose 0.05 mg/kg
0
7
0
7
4
7
EG007
6 Years to ≤ 12 Years Age Group: Multiple Dose 0.20 mg/kg
All (serious and nonserious) AEs for the 0 to < 2 years Age Group - Multiple Dose 0.20 mg/kg
0
10
2
10
10
10
EG008
2 Years to < 6 Years Age Group: Multiple Dose 0.20 mg/kg
All (serious and nonserious) AEs for the 2 to < 6 years Age Group - Multiple Dose 0.20 mg/kg
0
6
0
6
4
6
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Joint dislocation
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected7 at risk
EG004
Postoperative fever
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Fall
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected0 at risk
EG0080 events0 affected2 at risk
Postoperative fever
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Procedural anxiety
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0002 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Procedural vomiting
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Procedural nausea
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Blood blister
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Sinus arrhythmia
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Face oedema
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Generalised oedema
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Localised oedema
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Oedema peripheral
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Peripheral swelling
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Pyrexia
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0016 events3 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Clostridium test positive
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Haematocrit decreased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Red blood cell count decreased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Foot deformity
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Cerebrospinal fluid leakage
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Device dislocation
Product Issues
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Oedema genital
Reproductive system and breast disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Incisional drainage
Surgical and medical procedures
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events1 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Hypotension
Vascular disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected7 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Ileus paralytic
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Fatigue
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Oedema
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Headache
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Lethargy
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Sedation
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Vision blurred
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Infusion site oedema
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Central venous catheterisation
Surgical and medical procedures
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Coagulopathy
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Enuresis
Renal and urinary disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
Somnolence
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected7 at risk
EG003
This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.