Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01210352
Recruitment Status : Completed
First Posted : September 28, 2010
Results First Posted : May 7, 2019
Last Update Posted : August 20, 2021
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Post Operative Pain
Intervention Drug: oxymorphone HCl
Enrollment 61
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single Dose Phase 6 to ≤12 Years Age Group: 0.05 mg/kg Single-Dose Phase 6 to ≤12 Years Age Group: 0.10 mg/kg Single Dose Phase 6 to ≤12 Years Age Group: 0.20 mg/kg Single Dose Phase 2 to <6 Years Age Group: 0.05 mg/kg Single Dose Phase 2 to <6 Years Age Group: 0.10 mg/kg Single Dose Phase 2 to <6 Years Age Group: 0.20 mg/kg Single Dose Phase 0 to < 2 Years Age Group: 0.05 mg/kg Multiple Dose Phase 6 to ≤12 Years Age Group: 0.20 mg/kg Multiple Dose Phase 2 to <6 Years Age Group: 0.20 mg/kg
Hide Arm/Group Description 6 to ≤12 year age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid 6 to ≤12 year age group in the Single Dose Phase given 0.10 mg/kg oxymorphone HCl IR oral liquid 6 to ≤12 year age group in the Single Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid 2 to <6 Years age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid 2 to <6 Years age group in the Single Dose Phase given 0.10 mg/kg oxymorphone HCl IR oral liquid 2 to <6 Years age group in the Single Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid 0 to < 2 Years age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid 6 to ≤12 year age group in the Multiple Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid 2 to <6 year age group in the Multiple Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid
Period Title: Overall Study
Started 6 6 7 7 6 6 7 10 6
Completed 6 6 5 7 6 6 5 7 2
Not Completed 0 0 2 0 0 0 2 3 4
Reason Not Completed
Adverse Event             0             0             0             0             0             0             0             2             1
Lack of Efficacy             0             0             0             0             0             0             1             0             0
Physician Decision             0             0             0             0             0             0             0             1             2
Withdrawal by Subject             0             0             1             0             0             0             1             0             1
Patient Discharged Early             0             0             1             0             0             0             0             0             0
Arm/Group Title Single Dose Phase 6 to ≤12 Years Age Group: 0.05 mg/kg Single-Dose Phase 6 to ≤12 Years Age Group: 0.10 mg/kg Single Dose Phase 6 to ≤12 Years Age Group: 0.20 mg/kg Single Dose Phase 2 to <6 Years Age Group: 0.05 mg/kg Single Dose Phase 2 to <6 Years Age Group: 0.10 mg/kg Single Dose Phase 2 to <6 Years Age Group: 0.20 mg/kg Single Dose Phase 0 to < 2 Years Age Group: 0.05 mg/kg Multiple Dose Phase 6 to ≤12 Years Age Group: 0.20 mg/kg Multiple Dose Phase 2 to <6 Years Age Group: 0.20 mg/kg Total
Hide Arm/Group Description 6 to ≤12 year age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid 6 to ≤12 year age group in the Single Dose Phase given 0.10 mg/kg oxymorphone HCl IR oral liquid 6 to ≤12 year age group in the Single Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid 2 to <6 Years age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid 2 to <6 Years age group in the Single Dose Phase given 0.10 mg/kg oxymorphone HCl IR oral liquid 2 to <6 Years age group in the Single Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid 0 to < 2 Years age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid 6 to ≤12 year age group in the Multiple Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid 2 to <6 year age group in the Multiple Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid Total of all reporting groups
Overall Number of Baseline Participants 6 6 7 7 6 6 7 10 6 61
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 7 participants 7 participants 6 participants 6 participants 7 participants 10 participants 6 participants 61 participants
8.3  (1.75) 8.7  (1.86) 9.0  (2.16) 3.4  (1.27) 3.5  (1.38) 3.5  (1.38) 0.4  (0.53) 9.6  (1.90) 3.8  (1.17) 5.8  (3.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 7 participants 7 participants 6 participants 6 participants 7 participants 10 participants 6 participants 61 participants
Female
1
  16.7%
2
  33.3%
6
  85.7%
2
  28.6%
3
  50.0%
6
 100.0%
1
  14.3%
5
  50.0%
0
   0.0%
26
  42.6%
Male
5
  83.3%
4
  66.7%
1
  14.3%
5
  71.4%
3
  50.0%
0
   0.0%
6
  85.7%
5
  50.0%
6
 100.0%
35
  57.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 7 participants 7 participants 6 participants 6 participants 7 participants 10 participants 6 participants 61 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
0
   0.0%
2
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
3
   4.9%
Not Hispanic or Latino
6
 100.0%
6
 100.0%
6
  85.7%
7
 100.0%
6
 100.0%
4
  66.7%
7
 100.0%
10
 100.0%
6
 100.0%
58
  95.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 7 participants 7 participants 6 participants 6 participants 7 participants 10 participants 6 participants 61 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.6%
Asian
0
   0.0%
2
  33.3%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
   4.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  33.3%
1
  16.7%
0
   0.0%
3
  42.9%
1
  16.7%
0
   0.0%
1
  14.3%
3
  30.0%
1
  16.7%
12
  19.7%
White
4
  66.7%
3
  50.0%
6
  85.7%
4
  57.1%
4
  66.7%
6
 100.0%
6
  85.7%
7
  70.0%
5
  83.3%
45
  73.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 6 participants 6 participants 7 participants 7 participants 6 participants 6 participants 7 participants 10 participants 6 participants 61 participants
35.25  (11.725) 30.33  (17.731) 37.26  (20.613) 18.76  (4.026) 15.77  (4.303) 17.88  (4.869) 9.10  (3.106) 41.81  (18.103) 17.83  (2.701) 25.84  (16.311)
1.Primary Outcome
Title Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase
Hide Description

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).

Time Frame Baseline, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose; and at the time of rescue
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title 6 Years to ≤ 12 Years Age Group in Single Dose Phase 2 Years to < 6 Years Age Group in Single Dose Phase 0 Years to < 2 Years Age Group in Single Dose Phase
Hide Arm/Group Description:
Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group
Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to < 6 year age group
Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to < 2 years age group
Overall Number of Participants Analyzed 19 19 7
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline (Prior to Treatment) Number Analyzed 19 participants 19 participants 7 participants
4.5  (3.12) 3.4  (3.55) 2.4  (1.90)
15 Minutes Post Dose Number Analyzed 19 participants 18 participants 7 participants
3.5  (3.64) 1.2  (2.50) 1.3  (2.63)
30 Minutes Post Dose Number Analyzed 18 participants 18 participants 7 participants
2.7  (3.29) 1.2  (2.28) 0.4  (0.79)
1 Hour Post Dose Number Analyzed 18 participants 17 participants 7 participants
1.8  (1.93) 0.2  (0.56) 0.1  (0.38)
1.5 Hours Post Dose Number Analyzed 12 participants 11 participants 0 participants
2.0  (2.56) 0.2  (0.60)
2 Hours Post Dose Number Analyzed 15 participants 16 participants 7 participants
3.1  (3.37) 0.4  (0.81) 0.4  (0.79)
3 Hours Post Dose Number Analyzed 4 participants 3 participants 7 participants
0.0  (0.00) 2.0  (2.65) 0.4  (1.13)
4 Hours Post Dose Number Analyzed 12 participants 11 participants 6 participants
1.8  (2.17) 1.5  (2.34) 1.3  (1.51)
6 Hours Post Dose Number Analyzed 7 participants 9 participants 4 participants
2.3  (1.80) 0.7  (1.41) 0.8  (1.50)
8 Hours Post Dose Number Analyzed 3 participants 8 participants 3 participants
3.3  (5.77) 0.8  (1.39) 0.0  (0.00)
12 Hours Post Dose Number Analyzed 3 participants 6 participants 3 participants
1.3  (2.31) 0.0  (0.00) 0.0  (0.00)
24 Hours Post Dose Number Analyzed 0 participants 4 participants 2 participants
0.0  (0.00) 0.0  (0.00)
2.Primary Outcome
Title Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase
Hide Description

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.

Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title 6 Years to ≤ 12 Years Age Group in Single Dose Phase 2 Years to < 6 Years Age Group in Single Dose Phase 0 Years to < 2 Years Age Group in Single Dose Phase
Hide Arm/Group Description:
Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group
Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to < 6 year age group
Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to < 2 year age group
Overall Number of Participants Analyzed 19 19 7
Mean (Standard Deviation)
Unit of Measure: score on a scale
15 Minutes Post-Dose Number Analyzed 19 participants 18 participants 7 participants
1.1  (4.24) 2.1  (2.56) 1.1  (4.06)
30 Minutes Post-Dose Number Analyzed 18 participants 18 participants 7 participants
1.6  (3.33) 2.1  (2.49) 2.0  (2.45)
1 Hour Post-Dose Number Analyzed 18 participants 17 participants 7 participants
2.4  (3.67) 2.6  (3.10) 2.3  (1.98)
1.5 Hours Post-Dose Number Analyzed 12 participants 11 participants 0 participants
3.0  (3.86) 3.8  (3.84)
2 Hours Post-Dose Number Analyzed 15 participants 16 participants 7 participants
1.5  (4.03) 2.6  (3.40) 2.0  (2.45)
3 Hours Post-Dose Number Analyzed 4 participants 3 participants 7 participants
3.0  (2.00) -1.0  (2.00) 2.0  (2.31)
4 Hours Post-Dose Number Analyzed 12 participants 11 participants 6 participants
2.7  (4.21) 2.5  (3.24) 1.0  (2.83)
6 Hours Post-Dose Number Analyzed 7 participants 9 participants 4 participants
3.1  (4.14) 3.0  (2.40) 1.0  (2.71)
8 Hours Post-Dose Number Analyzed 3 participants 8 participants 3 participants
1.3  (2.31) 2.4  (2.92) 1.7  (2.89)
12 Hours Post-Dose Number Analyzed 3 participants 6 participants 3 participants
3.3  (5.77) 3.2  (2.32) 1.7  (2.89)
24 Hours Post-Dose Number Analyzed 0 participants 4 participants 2 participants
3.0  (2.16) 0.0  (0.00)
3.Primary Outcome
Title Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase
Hide Description

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)

Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 6 Years to ≤ 12 Years Age Group in Multiple Dose Phase 2 Years to < 6 Years Age Group in Multiple Dose Phase
Hide Arm/Group Description:
Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group
Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to < 6 year age group
Overall Number of Participants Analyzed 10 6
Mean (Standard Deviation)
Unit of Measure: score on a scale
Dose 1, Baseline (Prior to Treatment) Number Analyzed 9 participants 6 participants
3.1  (2.67) 3.5  (3.27)
Dose 1, 30 Minutes Post Dose Number Analyzed 9 participants 6 participants
2.7  (1.73) 1.3  (1.97)
Dose 1, 1 Hour Post Dose Number Analyzed 10 participants 5 participants
2.0  (2.83) 1.8  (2.05)
Dose 1, 1.5 Hours Post Dose Number Analyzed 8 participants 4 participants
2.3  (1.67) 0.0  (0.00)
Dose 1, 2 Hours Post Dose Number Analyzed 8 participants 4 participants
2.8  (2.38) 0.0  (0.00)
Dose 2, 0 Hour Number Analyzed 7 participants 3 participants
4.0  (3.27) 5.0  (2.65)
Dose 3, 0 Hour Number Analyzed 5 participants 3 participants
5.6  (2.61) 3.7  (3.21)
Dose 4, 0 Hour Number Analyzed 6 participants 2 participants
4.0  (3.58) 4.5  (0.71)
Dose 5, 0 Hour Number Analyzed 4 participants 2 participants
2.5  (1.00) 5.0  (0.00)
Dose 6, 0 Hour Number Analyzed 4 participants 1 participants
2.5  (1.00) 6.0 [1]   (NA)
Dose 7, 0 Hour Number Analyzed 4 participants 0 participants
3.0  (2.00)
Dose 8, 0 Hour Number Analyzed 3 participants 0 participants
4.7  (2.31)
Dose 9, 0 Hour Number Analyzed 3 participants 0 participants
1.3  (1.15)
Dose 10, 0 Hour Number Analyzed 3 participants 0 participants
2.0  (0.00)
Dose 11, 0 Hour Number Analyzed 2 participants 0 participants
2.0  (0.00)
Dose 12, 0 Hour Number Analyzed 2 participants 0 participants
5.0  (4.24)
End of Study/Early Termination Number Analyzed 4 participants 4 participants
4.0  (1.63) 1.3  (2.50)
[1]
SD cannot be derived based on one subject data point
4.Primary Outcome
Title Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase
Hide Description

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.

Time Frame 0.5, 1, 1.5, 2, hours post dose 1 through to Dose 12, 0 Hour; End of Study/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 6 to ≤12 Years Age Group: 0.20 mg/kg 2 to <6 Years Age Group: 0.20 mg/kg
Hide Arm/Group Description:
Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group
Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to < 6 year age group
Overall Number of Participants Analyzed 10 6
Mean (Standard Deviation)
Unit of Measure: score on a scale
Dose 1, 30 Minutes Post-Dose Number Analyzed 9 participants 6 participants
0.4  (2.19) 2.2  (2.79)
Dose 1, 1 Hour Post-Dose Number Analyzed 9 participants 5 participants
0.9  (2.67) 2.0  (3.46)
Dose 1, 1.5 Hours Post-Dose Number Analyzed 7 participants 4 participants
1.1  (3.02) 4.8  (3.30)
Dose 1, 2 Hours Post-Dose Number Analyzed 8 participants 4 participants
0.0  (1.85) 4.8  (3.30)
Dose 2, 0 Hour Number Analyzed 6 participants 3 participants
-2.3  (3.88) 0.3  (1.53)
Dose 3, 0 Hour Number Analyzed 4 participants 3 participants
-3.5  (4.43) 1.7  (0.58)
Dose 4, 0 Hour Number Analyzed 5 participants 2 participants
-0.8  (3.03) 3.0  (1.41)
Dose 5, 0 Hour Number Analyzed 4 participants 2 participants
1.0  (1.15) 2.5  (0.71)
Dose 6, 0 Hour Number Analyzed 4 participants 1 participants
1.0  (2.58) 2.0 [1]   (NA)
Dose 7, 0 Hour Number Analyzed 4 participants 0 participants
0.5  (2.52)
Dose 8, 0 Hour Number Analyzed 3 participants 0 participants
-2.0  (2.00)
Dose 9, 0 Hour Number Analyzed 3 participants 0 participants
2.7  (1.15)
Dose 10, 0 Hour Number Analyzed 3 participants 0 participants
2.0  (2.00)
Dose 11, 0 Hour Number Analyzed 2 participants 0 participants
3.0  (1.41)
Dose 12, 0 Hour Number Analyzed 2 participants 0 participants
0.0  (5.66)
End of Study/Early Termination Number Analyzed 4 participants 4 participants
-0.5  (1.91) 3.5  (3.11)
[1]
Not determined, or not reported due to insufficient data for reliable estimate
5.Primary Outcome
Title Number (%) of Subjects With Rescue Medication Use by Age and Dose Group in Multiple-Dose Phase
Hide Description Rescue Medication Use in Multiple Dose Phase
Time Frame Rescue Medication Use
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 6 to ≤12 Years Age Group: 0.20 mg/kg 2 to <6 Years Age Group: 0.20 mg/kg
Hide Arm/Group Description:
Percentages are based on the number of subjects ('N') in effectiveness population in each dose group in each age group in Multiple-Dose Phase
Percentages are based on the number of subjects ('N') in effectiveness population in each dose group in each age group in Multiple-Dose Phase
Overall Number of Participants Analyzed 10 6
Measure Type: Count of Participants
Unit of Measure: Participants
Rescue Medication Used
5
  50.0%
2
  33.3%
No Rescue Medication needed
5
  50.0%
4
  66.7%
6.Secondary Outcome
Title 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
Hide Description Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Arm/Group Title 0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Hide Arm/Group Description:
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Overall Number of Participants Analyzed 6 7 6 6 7 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.415  (0.211) 0.33  (0.217) 1.14  (0.847) 1.76  (1.62) 1.33  (0.772) 3.16  (1.65)
7.Secondary Outcome
Title 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
Hide Description Tmax: The time at which Cmax was observed
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Arm/Group Title 0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Hide Arm/Group Description:
Tmax: The time at which Cmax was observed
Tmax: The time at which Cmax was observed
Tmax: The time at which Cmax was observed
Tmax: The time at which Cmax was observed
Tmax: The time at which Cmax was observed
Tmax: The time at which Cmax was observed
Overall Number of Participants Analyzed 6 7 6 6 7 6
Mean (Standard Deviation)
Unit of Measure: h
2.7  (1.66) 2.64  (1.03) 1.38  (1.3) 1.45  (1.39) 2.49  (3.17) 1.59  (1.38)
8.Secondary Outcome
Title 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
Hide Description Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Arm/Group Title 0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Hide Arm/Group Description:
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Overall Number of Participants Analyzed 6 7 6 6 7 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.0759  (0.072) 0.0618  (0.0389) 0.11  (0.0847) 0.0671  (0.0376) 0.269  (0.182) 0.645  (1.3)
9.Secondary Outcome
Title 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
Hide Description Tlast: The time at which Clast was observed
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Arm/Group Title 0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Hide Arm/Group Description:
Tlast: The time at which Clast was observed
Tlast: The time at which Clast was observed
Tlast: The time at which Clast was observed
Tlast: The time at which Clast was observed
Tlast: The time at which Clast was observed
Tlast: The time at which Clast was observed
Overall Number of Participants Analyzed 6 7 6 6 7 6
Mean (Standard Deviation)
Unit of Measure: h
15.4  (7.01) 13.2  (5.06) 18  (6.55) 16  (8.04) 12.6  (9.85) 18.4  (8.97)
10.Secondary Outcome
Title 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
Hide Description AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Arm/Group Title 0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Hide Arm/Group Description:
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
Overall Number of Participants Analyzed 6 7 6 6 7 6
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
2.56  (2) 1.69  (0.943) 3.01  (0.766) 3.99  (2.09) 5.32  (4.53) 9.37  (5.81)
11.Secondary Outcome
Title 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
Hide Description AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Arm/Group Title 0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Hide Arm/Group Description:
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
Overall Number of Participants Analyzed 2 2 2 3 3 2
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
NA [1]   (0.0516) 3.22  (1.56) 3.01  (0.946) 3.69  (3.12) 6.92  (4.02) 14.3  (5.01)
[1]
Not determined, or not reported due to insufficient data for reliable estimate
12.Secondary Outcome
Title 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
Hide Description AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Arm/Group Title 0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Hide Arm/Group Description:
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
Overall Number of Participants Analyzed 3 3 4 4 4 2
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
3.75  (2.32) 2.65  (1.4) 3.01  (0.905) 3.69  (2.44) 6.11  (2.83) 14  (4.72)
13.Secondary Outcome
Title 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
Hide Description t1/2: Terminal half-life, calculated as λn/(ln 2)
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Arm/Group Title 0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Hide Arm/Group Description:
t1/2: Terminal half-life, calculated as λn/(ln 2)
t1/2: Terminal half-life, calculated as λn/(ln 2)
t1/2: Terminal half-life, calculated as λn/(ln 2)
t1/2: Terminal half-life, calculated as λn/(ln 2)
t1/2: Terminal half-life, calculated as λn/(ln 2)
t1/2: Terminal half-life, calculated as λn/(ln 2)
Overall Number of Participants Analyzed 2 2 2 3 3 2
Mean (Standard Deviation)
Unit of Measure: h
NA [1]   (0.232) 5.01  (1.4) 7.5  (7.33) 4.38  (2.9) 5.13  (3.16) 4.39  (1.16)
[1]
Not determined, or not reported due to insufficient data for reliable estimate
14.Secondary Outcome
Title 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
Hide Description CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Combined 0.05, 0.1, and 0.2 mg/kg - Aged 6 Years to ≤ 12 Years Combined 0.05, 0.1, and 0.2 mg/kg - Aged 2 Years to <6 Years
Hide Arm/Group Description:
CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf
CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: L/h/kg
31.2  (13.6) 26.4  (18.8)
15.Secondary Outcome
Title 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
Hide Description V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf * λn)
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Combined 0.05, 0.1, and 0.2 mg/kg - Aged 6 Years to ≤ 12 Years Combined 0.05, 0.1, and 0.2 mg/kg - Aged 2 Years to <6 Years
Hide Arm/Group Description:
V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf * λn)
V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf * λn)
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: L/kg
205  (145) 154  (121)
16.Secondary Outcome
Title 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
Hide Description Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Hide Arm/Group Description:
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Overall Number of Participants Analyzed 10 5 3 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
1.46  (1.16) 2.58  (1.24) 2.66  (0.805)
17.Secondary Outcome
Title 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
Hide Description Tmax: The time at which Cmax was observed
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Hide Arm/Group Description:
Tmax: The time at which Cmax was observed
Tmax: The time at which Cmax was observed
Tmax: The time at which Cmax was observed
Tmax: The time at which Cmax was observed
Overall Number of Participants Analyzed 10 5 3 0
Mean (Standard Deviation)
Unit of Measure: h
1.37  (0.599) 0.967  (0.622) 1.21  (1.1)
18.Secondary Outcome
Title 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
Hide Description Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Hide Arm/Group Description:
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Overall Number of Participants Analyzed 10 5 3 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.452  (0.286) 0.508  (0.32) 2.3  (0.745)
19.Secondary Outcome
Title 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
Hide Description Tlast: The time at which Clast was observed
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Hide Arm/Group Description:
Tlast: The time at which Clast was observed
Tlast: The time at which Clast was observed
Tlast: The time at which Clast was observed
Tlast: The time at which Clast was observed
Overall Number of Participants Analyzed 10 5 3 0
Mean (Standard Deviation)
Unit of Measure: h
4  (0.971) 4.47  (1.68) 2.09  (0.077)
20.Secondary Outcome
Title 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
Hide Description AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Hide Arm/Group Description:
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
Overall Number of Participants Analyzed 10 5 3 0
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
3.49  (3.22) 3.88  (1.45) 4.24  (0.9)
21.Secondary Outcome
Title 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
Hide Description AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Arm/Group Title 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Hide Arm/Group Description:
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
Overall Number of Participants Analyzed 3 3 0 0
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
4.01  (1.43) 4.53  (2.21)
22.Secondary Outcome
Title 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
Hide Description AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Arm/Group Title 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Hide Arm/Group Description:
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
Overall Number of Participants Analyzed 3 3 0 0
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
4.01  (1.42) 4.53  (2.21)
23.Secondary Outcome
Title 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
Hide Description t1/2: Terminal half-life, calculated as λn/(ln 2)
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Arm/Group Title 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Hide Arm/Group Description:
t1/2: Terminal half-life, calculated as λn/(ln 2)
t1/2: Terminal half-life, calculated as λn/(ln 2)
t1/2: Terminal half-life, calculated as λn/(ln 2)
t1/2: Terminal half-life, calculated as λn/(ln 2)
Overall Number of Participants Analyzed 3 3 0 0
Mean (Standard Deviation)
Unit of Measure: h
2.18  (0.459) 1.17  (0.632)
24.Secondary Outcome
Title 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
Hide Description Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Arm/Group Title 0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Hide Arm/Group Description:
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Overall Number of Participants Analyzed 6 7 6 6 7 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.104  (0.0555) 0.1  (0.073) 0.384  (0.177) 0.437  (0.419) 0.603  (0.513) 0.587  (0.182)
25.Secondary Outcome
Title 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
Hide Description Tmax: The time at which Cmax was observed
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Arm/Group Title 0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Hide Arm/Group Description:
Tmax: The time at which Cmax was observed
Tmax: The time at which Cmax was observed
Tmax: The time at which Cmax was observed
Tmax: The time at which Cmax was observed
Tmax: The time at which Cmax was observed
Tmax: The time at which Cmax was observed
Overall Number of Participants Analyzed 5 7 6 6 7 6
Mean (Standard Deviation)
Unit of Measure: h
2.86  (1.17) 2.91  (1.11) 1.38  (1.3) 1.86  (1.69) 3.08  (3.42) 1.93  (1.71)
26.Secondary Outcome
Title 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
Hide Description Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Arm/Group Title 0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Hide Arm/Group Description:
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Overall Number of Participants Analyzed 5 7 6 6 7 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.0453  (0.0272) 0.0418  (0.0152) 0.0568  (0.0292) 0.0332  (0.0183) 0.204  (0.188) 0.0994  (0.144)
27.Secondary Outcome
Title 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
Hide Description Tlast: The time at which Clast was observed
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Arm/Group Title 0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Hide Arm/Group Description:
Tlast: The time at which Clast was observed
Tlast: The time at which Clast was observed
Tlast: The time at which Clast was observed
Tlast: The time at which Clast was observed
Tlast: The time at which Clast was observed
Tlast: The time at which Clast was observed
Overall Number of Participants Analyzed 5 7 6 6 7 6
Mean (Standard Deviation)
Unit of Measure: h
9.66  (8.25) 8.86  (7.82) 14.4  (7.86) 16.1  (9.05) 12.6  (9.85) 18.4  (8.97)
28.Secondary Outcome
Title 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
Hide Description AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Arm/Group Title 0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Hide Arm/Group Description:
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
Overall Number of Participants Analyzed 6 7 6 6 7 6
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
0.459  (0.396) 0.467  (0.473) 1.22  (0.761) 1.27  (0.637) 2.64  (2.52) 2.26  (1.07)
29.Secondary Outcome
Title 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
Hide Description AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Arm/Group Title 0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Hide Arm/Group Description:
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
Overall Number of Participants Analyzed 1 1 1 4 2 2
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
1.83 [1]   (NA) 1.11 [1]   (NA) 0.535 [1]   (NA) 1.76  (0.762) 7.58  (5.12) 2.76  (0.399)
[1]
Not determined, or not reported due to insufficient data for reliable estimate
30.Secondary Outcome
Title 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
Hide Description AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Arm/Group Title 0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Hide Arm/Group Description:
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
Overall Number of Participants Analyzed 1 1 3 5 4 2
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
1.09 [1]   (NA) 1.09 [1]   (NA) 1.08  (0.484) 1.45  (0.588) 3.08  (1.32) 2.61  (0.226)
[1]
Not determined, or not reported due to insufficient data for reliable estimate
31.Secondary Outcome
Title 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
Hide Description t1/2: Terminal half-life, calculated as λn/(ln 2)
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Arm/Group Title 0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Hide Arm/Group Description:
t1/2: Terminal half-life, calculated as λn/(ln 2)
t1/2: Terminal half-life, calculated as λn/(ln 2)
t1/2: Terminal half-life, calculated as λn/(ln 2)
t1/2: Terminal half-life, calculated as λn/(ln 2)
t1/2: Terminal half-life, calculated as λn/(ln 2)
t1/2: Terminal half-life, calculated as λn/(ln 2)
Overall Number of Participants Analyzed 1 1 1 4 2 2
Mean (Standard Deviation)
Unit of Measure: h
20.5 [1]   (NA) 4.48 [1]   (NA) 2.31 [1]   (NA) 8.67  (8.06) 18.7  (22.5) 5.18  (2.55)
[1]
Not determined, or not reported due to insufficient data for reliable estimate
32.Secondary Outcome
Title 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
Hide Description CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Combined 0.05, 0.1, and 0.2 mg/kg - Aged 6 Years to ≤ 12 Years Combined 0.05, 0.1, and 0.2 mg/kg - Aged 2 Years to <6 Years
Hide Arm/Group Description:
CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf
CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf
Overall Number of Participants Analyzed 4 7
Mean (Standard Deviation)
Unit of Measure: L/h/kg
70.7  (78.8) 65  (23.2)
33.Secondary Outcome
Title 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
Hide Description V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf * λn)
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Combined 0.05, 0.1, and 0.2 mg/kg - Aged 6 Years to ≤ 12 Years Combined 0.05, 0.1, and 0.2 mg/kg - Aged 2 Years to <6 Years
Hide Arm/Group Description:
V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf * λn)
V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf * λn)
Overall Number of Participants Analyzed 4 7
Mean (Standard Deviation)
Unit of Measure: L/kg
631  (308) 575  (487)
34.Secondary Outcome
Title 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
Hide Description Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Hide Arm/Group Description:
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Overall Number of Participants Analyzed 10 5 3 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.547  (0.472) 0.829  (0.541) 1.41  (0.473)
35.Secondary Outcome
Title 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
Hide Description Tmax: The time at which Cmax was observed
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Hide Arm/Group Description:
Tmax: The time at which Cmax was observed
Tmax: The time at which Cmax was observed
Tmax: The time at which Cmax was observed
Tmax: The time at which Cmax was observed
Overall Number of Participants Analyzed 10 5 3 0
Mean (Standard Deviation)
Unit of Measure: h
1.67  (1.01) 1.37  (1.5) 1.36  (0.85)
36.Secondary Outcome
Title 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
Hide Description Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Hide Arm/Group Description:
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Overall Number of Participants Analyzed 10 5 3 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.201  (0.118) 0.225  (0.139) 1.25  (0.585)
37.Secondary Outcome
Title 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
Hide Description Tlast: The time at which Clast was observed
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Hide Arm/Group Description:
Tlast: The time at which Clast was observed
Tlast: The time at which Clast was observed
Tlast: The time at which Clast was observed
Tlast: The time at which Clast was observed
Overall Number of Participants Analyzed 10 5 3 0
Mean (Standard Deviation)
Unit of Measure: h
3.97  (1.05) 4.47  (1.68) 2.09  (0.077)
38.Secondary Outcome
Title 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
Hide Description AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Hide Arm/Group Description:
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
Overall Number of Participants Analyzed 10 5 3 0
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
1.35  (1.27) 1.61  (1.19) 2.25  (0.547)
39.Secondary Outcome
Title 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
Hide Description AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Arm/Group Title 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Hide Arm/Group Description:
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
Overall Number of Participants Analyzed 3 3 1 0
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
2.15  (0.769) 1.79  (1.73) 7.66 [1]   (NA)
[1]
Not determined, or not reported due to insufficient data for reliable estimate
40.Secondary Outcome
Title 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
Hide Description AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Arm/Group Title 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Hide Arm/Group Description:
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
Overall Number of Participants Analyzed 3 3 1 0
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
2.11  (0.748) 1.78  (1.72) 7.38 [1]   (NA)
[1]
Not determined, or not reported due to insufficient data for reliable estimate
41.Secondary Outcome
Title 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
Hide Description t1/2: Terminal half-life, calculated as λn/(ln 2)
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
Arm/Group Title 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1 0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7 0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Hide Arm/Group Description:
t1/2: Terminal half-life, calculated as λn/(ln 2)
t1/2: Terminal half-life, calculated as λn/(ln 2)
t1/2: Terminal half-life, calculated as λn/(ln 2)
t1/2: Terminal half-life, calculated as λn/(ln 2)
Overall Number of Participants Analyzed 3 3 1 0
Mean (Standard Deviation)
Unit of Measure: h
3.61  (1.67) 1.42  (0.73) 4.9 [1]   (NA)
[1]
Not determined, or not reported due to insufficient data for reliable estimate
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.
Adverse Event Reporting 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.
 
Arm/Group Title 6 Years to ≤ 12 Years Age Group: Single Dose 0.05 mg/kg 6 Years to ≤ 12 Years Age Group: Single Dose 0.10 mg/kg 6 Years to ≤ 12 Years Age Group: Single Dose 0.20 mg/kg 2 Years to < 6 Years Age Group: Single Dose 0.05 mg/kg 2 Years to < 6 Years Age Group: Single Dose 0.10 mg/kg 2 Years to < 6 Years Age Group: Single Dose 0.20 mg/kg 0 to < 2 Years Age Group: Single Dose 0.05 mg/kg 6 Years to ≤ 12 Years Age Group: Multiple Dose 0.20 mg/kg 2 Years to < 6 Years Age Group: Multiple Dose 0.20 mg/kg
Hide Arm/Group Description All (serious and nonserious) AEs for the 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 0.10 mg/kg All (serious and nonserious) AEs for the 6 years to ≤ 12 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 0.05 mg/kg All (serious and nonserious) AEs for the 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 0.20 mg/kg All (serious and nonserious) AEs for the 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 - 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
All-Cause Mortality
6 Years to ≤ 12 Years Age Group: Single Dose 0.05 mg/kg 6 Years to ≤ 12 Years Age Group: Single Dose 0.10 mg/kg 6 Years to ≤ 12 Years Age Group: Single Dose 0.20 mg/kg 2 Years to < 6 Years Age Group: Single Dose 0.05 mg/kg 2 Years to < 6 Years Age Group: Single Dose 0.10 mg/kg 2 Years to < 6 Years Age Group: Single Dose 0.20 mg/kg 0 to < 2 Years Age Group: Single Dose 0.05 mg/kg 6 Years to ≤ 12 Years Age Group: Multiple Dose 0.20 mg/kg 2 Years to < 6 Years Age Group: Multiple Dose 0.20 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)      0/6 (0.00%)      0/7 (0.00%)      0/7 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/7 (0.00%)      0/10 (0.00%)      0/6 (0.00%)    
Hide Serious Adverse Events
6 Years to ≤ 12 Years Age Group: Single Dose 0.05 mg/kg 6 Years to ≤ 12 Years Age Group: Single Dose 0.10 mg/kg 6 Years to ≤ 12 Years Age Group: Single Dose 0.20 mg/kg 2 Years to < 6 Years Age Group: Single Dose 0.05 mg/kg 2 Years to < 6 Years Age Group: Single Dose 0.10 mg/kg 2 Years to < 6 Years Age Group: Single Dose 0.20 mg/kg 0 to < 2 Years Age Group: Single Dose 0.05 mg/kg 6 Years to ≤ 12 Years Age Group: Multiple Dose 0.20 mg/kg 2 Years to < 6 Years Age Group: Multiple Dose 0.20 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      1/6 (16.67%)      0/7 (0.00%)      1/7 (14.29%)      0/6 (0.00%)      0/6 (0.00%)      0/7 (0.00%)      2/10 (20.00%)      0/6 (0.00%)    
Blood and lymphatic system disorders                   
Neutropenia  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
Infections and infestations                   
Abdominal abscess  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/6 (0.00%)  0
Injury, poisoning and procedural complications                   
Joint dislocation  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
Postoperative fever  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
Wound dehiscence  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/6 (0.00%)  0
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
6 Years to ≤ 12 Years Age Group: Single Dose 0.05 mg/kg 6 Years to ≤ 12 Years Age Group: Single Dose 0.10 mg/kg 6 Years to ≤ 12 Years Age Group: Single Dose 0.20 mg/kg 2 Years to < 6 Years Age Group: Single Dose 0.05 mg/kg 2 Years to < 6 Years Age Group: Single Dose 0.10 mg/kg 2 Years to < 6 Years Age Group: Single Dose 0.20 mg/kg 0 to < 2 Years Age Group: Single Dose 0.05 mg/kg 6 Years to ≤ 12 Years Age Group: Multiple Dose 0.20 mg/kg 2 Years to < 6 Years Age Group: Multiple Dose 0.20 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/6 (83.33%)      4/6 (66.67%)      4/7 (57.14%)      7/7 (100.00%)      5/6 (83.33%)      3/6 (50.00%)      4/7 (57.14%)      10/10 (100.00%)      4/6 (66.67%)    
Blood and lymphatic system disorders                   
Coagulopathy  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 1/6 (16.67%)  1
Cardiac disorders                   
Bradycardia  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
Sinus arrhythmia  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
Tachycardia  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
Gastrointestinal disorders                   
Abdominal distension  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 2/7 (28.57%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
Constipation  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/6 (0.00%)  0
Diarrhoea  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/6 (0.00%)  0
Nausea  1  0/6 (0.00%)  0 1/6 (16.67%)  1 1/7 (14.29%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 4/10 (40.00%)  4 0/6 (0.00%)  0
Vomiting  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0 1/7 (14.29%)  1 4/10 (40.00%)  5 0/6 (0.00%)  0
Ileus paralytic  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/6 (0.00%)  0
General disorders                   
Face oedema  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
Generalised oedema  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
Localised oedema  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/10 (0.00%)  0 0/6 (0.00%)  0
Oedema peripheral  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 2/7 (28.57%)  3 0/6 (0.00%)  0 0/6 (0.00%)  0 2/7 (28.57%)  3 0/10 (0.00%)  0 1/6 (16.67%)  1
Peripheral swelling  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 1/7 (14.29%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
Pyrexia  1  0/6 (0.00%)  0 3/6 (50.00%)  6 1/7 (14.29%)  1 0/7 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 2/10 (20.00%)  2 1/6 (16.67%)  1
Fatigue  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/6 (0.00%)  0
Oedema  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/6 (0.00%)  0
Injury, poisoning and procedural complications                   
Fall  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/0  0 0/2 (0.00%)  0
Postoperative fever  1  1/6 (16.67%)  1 1/6 (16.67%)  1 0/7 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/0  0 0/2 (0.00%)  0
Procedural anxiety  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
Procedural pain  1  1/6 (16.67%)  2 0/6 (0.00%)  0 0/7 (0.00%)  0 2/7 (28.57%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
Procedural vomiting  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
Procedural nausea  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 2/7 (28.57%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
Infusion site oedema  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/6 (0.00%)  0
Investigations                   
Alanine aminotransferase increased  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/10 (0.00%)  0 0/6 (0.00%)  0
Aspartate aminotransferase increased  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 1/10 (10.00%)  1 0/6 (0.00%)  0
Clostridium test positive  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
Haematocrit decreased  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/10 (0.00%)  0 0/6 (0.00%)  0
Red blood cell count decreased  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/10 (0.00%)  0 0/6 (0.00%)  0
White blood cell count decreased  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/10 (0.00%)  0 0/6 (0.00%)  0
Haemoglobin decreased  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/10 (0.00%)  0 0/6 (0.00%)  0
Musculoskeletal and connective tissue disorders                   
Foot deformity  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
Muscle spasms  1  0/6 (0.00%)  0 2/6 (33.33%)  2 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
Arthralgia  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/6 (0.00%)  0
Nervous system disorders                   
Cerebrospinal fluid leakage  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
Headache  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 2/10 (20.00%)  2 0/6 (0.00%)  0
Lethargy  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/6 (0.00%)  0
Sedation  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/6 (0.00%)  0
Vision blurred  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/6 (0.00%)  0
Somnolence  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 1/6 (16.67%)  1
Product Issues                   
Device dislocation  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
Psychiatric disorders                   
Anxiety  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
Renal and urinary disorders                   
Enuresis  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 1/6 (16.67%)  1
Reproductive system and breast disorders                   
Oedema genital  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                   
Hypoxia  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
Atelectasis  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/6 (0.00%)  0
Pleural effusion  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders                   
Pruritus  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 1/6 (16.67%)  1
Blood blister  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
Dermatitis contact  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
Erythema  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
Rash  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
Swelling face  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
Surgical and medical procedures                   
Incisional drainage  1  0/6 (0.00%)  0 1/6 (16.67%)  3 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
Central venous catheterisation  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/6 (0.00%)  0
Vascular disorders                   
Hypotension  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Saji Vijayan
Organization: Endo Pharmaceuticals
Phone: (800) 462-3636
EMail: ClinicalTrials@Endo.com
Layout table for additonal information
Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01210352    
Other Study ID Numbers: EN3319-302
First Submitted: September 17, 2010
First Posted: September 28, 2010
Results First Submitted: December 20, 2018
Results First Posted: May 7, 2019
Last Update Posted: August 20, 2021