Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects
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ClinicalTrials.gov Identifier: NCT01210352 |
Recruitment Status :
Completed
First Posted : September 28, 2010
Results First Posted : May 7, 2019
Last Update Posted : August 20, 2021
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Sponsor:
Endo Pharmaceuticals
Information provided by (Responsible Party):
Endo Pharmaceuticals
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Study Type | Interventional |
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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 |
Participant Flow
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 |
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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 |
Baseline Characteristics
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 | |
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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 | |
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[Not Specified]
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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) |
Outcome Measures
Adverse Events
Limitations and Caveats
This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.
More Information
Results Point of Contact
Name/Title: | Saji Vijayan |
Organization: | Endo Pharmaceuticals |
Phone: | (800) 462-3636 |
EMail: | ClinicalTrials@Endo.com |
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 |