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

Post Operative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01210352
• Other study ID #: EN3319-302
• Status: Completed
• Phase: Phase 3
• Start date: December 13, 2010
• Est. completion date: October 6, 2017

Study information

• Verified date: May 2019
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 6, 2017
• Est. primary completion date: October 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Years

Eligibility

Inclusion Criteria:

1. Males or females between 2 to =12 years of age. Females of child-bearing potential must be practicing abstinence or using a medically acceptable form of contraception (eg, intrauterine device, hormonal birth control, or double barrier method). For the purpose of this study, all peri- and post-pubertal females will be considered to be of child-bearing potential unless they are biologically sterile or surgically sterile for more than 1 year

2. Subjects must be at least 10 kg and BMI =30

3. Scheduled to have a surgery for which oral opioid analgesia will be needed to manage postoperative pain for at least 24 hours (Single-Dose Phase) or 48 hours (Multiple-Dose Phase)following intraoperative and/or postoperative parenteral analgesia

4. Be hospital inpatients, expected to be hospitalized for at least 24 hours (Single-Dose Phase) and 48 hours (Multiple-Dose Phase) following the initial administration of oxymorphone immediate release

5. Available lab results, either intraoperatively (prior to surgical incision) or from within 21 days preoperatively, for clinical chemistry and hematology laboratory analytes (the results must have been reviewed by the Investigator for study eligibility)

6. Able to provide pain assessment evaluations using an age-appropriate instrument provided in the protocol

7. On an intravenous analgesic regimen utilizing a short-acting opioid analgesic following surgery AND anticipated to be switched to an oral opioid as part of the analgesic regimen (according to institution SOC)

8. Demonstrated the ability to tolerate clear fluids following surgery according to the SOC at each institution

9. Informed of the nature of the study and written informed consent has been obtained from the legally responsible parent(s)/legal guardian(s)

10. Provided assent in accordance with IRB requirements

11. Line in place for blood sampling

Exclusion Criteria:

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

2. Known sensitivity to any component of the study drug

3. Life expectancy <4 weeks

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

5. Pregnant and/or lactating

6. Cyanotic heart disease

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

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

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

10. Increased intracranial pressure

11. Respiratory condition requiring intubation

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

13. Significant prior history of substance abuse or alcohol abuse

14. Received any investigational drug within 30 days prior to the first dose of study drug, or are scheduled to receive an investigational drug other than oxymorphone HCl immediate-release oral liquid during the course of the study

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

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

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

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

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

Locations

Country	Name	City	State
United States	Endo Clinical Trial Site #3	Aurora	Colorado
United States	Endo Clinical Trial Site #14	Dallas	Texas
United States	Endo Clinical Trial Site #6	Indianapolis	Indiana
United States	Endo Clinical Trial Site #1	Little Rock	Arkansas
United States	Endo Clinical Trial Site #13	Nashville	Tennessee
United States	Endo Clinical Trial Site #11	Oklahoma City	Oklahoma
United States	Endo Clinical Trial Site #12	Pittsburgh	Pennsylvania
United States	Endo Clinical Trial Site #19	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Baseline, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose; and at the time of rescue
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.	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
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)	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
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.	0.5, 1, 1.5, 2, hours post dose 1 through to Dose 12, 0 Hour; End of Study/Early Termination
Primary	Number (%) of Subjects With Rescue Medication Use by Age and Dose Group in Multiple-Dose Phase	Rescue Medication Use in Multiple Dose Phase	Rescue Medication Use
Secondary	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
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	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
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	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
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	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
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	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
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/?n	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
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	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
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 ?n/(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
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	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
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 * ?n)	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
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	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
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	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
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	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
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	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
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	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
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/?n	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
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	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
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 ?n/(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
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	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
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	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
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	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
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	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
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	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
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/?n	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
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	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
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 ?n/(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
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	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
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 * ?n)	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
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	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
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	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
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	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
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	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
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	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
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/?n	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
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	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
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 ?n/(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