Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.
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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: NCT00801398 |
Recruitment Status :
Completed
First Posted : December 3, 2008
Results First Posted : February 27, 2019
Last Update Posted : February 27, 2019
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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 |
Postoperative Pain |
Intervention |
Drug: Oxymorphone IR |
Enrollment | 58 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Single Dose of Oxymorphone IR: 5mg Tablet | Single Dose of Oxymorphone IR: 10mg Tablet | Single Dose of Oxymorphone IR: 15mg Tablet | Multiple Dose of Oxymorphone: 5mg Tablet | Multiple Dose of Oxymorphone IR: 10mg Tablet | Multiple Dose of Oxymorphone IR: 15mg Tablet |
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[Not Specified] | [Not Specified] | [Not Specified] | [Not Specified] | [Not Specified] | [Not Specified] |
Period Title: Overall Study | ||||||
Started | 13 | 9 | 11 | 9 | 8 | 8 |
Completed | 7 | 0 | 4 | 3 | 1 | 5 |
Not Completed | 6 | 9 | 7 | 6 | 7 | 3 |
Baseline Characteristics
Arm/Group Title | Single Dose of Oxymorphone IR: 5mg Tablet | Single Dose of Oxymorphone IR: 10mg Tablet | Single Dose of Oxymorphone IR: 15mg Tablet | Multiple Dose of Oxymorphone IR: 5mg Tablet | Multiple Dose of Oxymorphone IR: 10mg Tablet | Multiple Dose of Oxymorphone IR: 15mg Tablet | Total | |
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[Not Specified] | [Not Specified] | [Not Specified] | [Not Specified] | [Not Specified] | [Not Specified] | Total of all reporting groups | |
Overall Number of Baseline Participants | 13 | 9 | 11 | 9 | 8 | 8 | 58 | |
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ITT Population; Single Dose Total = 33; Multiple Dose Total = 25;
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Age, Continuous
[1] Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 13 participants | 9 participants | 11 participants | 9 participants | 8 participants | 8 participants | 58 participants | |
14.9 (1.71) | 15.3 (1.66) | 14.6 (1.63) | 15.0 (0.71) | 15.3 (1.58) | 15.5 (1.07) | 15.07 (1.44) | ||
[1]
Measure Analysis Population Description: Single Dose of Oxymorphone IR Overall (N=33): Mean 14.9 SD (1.64) Multiple Dose of Oxymorphone IR Overall (N=25): Mean 15.2 SD (1.13)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 13 participants | 9 participants | 11 participants | 9 participants | 8 participants | 8 participants | 58 participants | |
Female |
9 69.2%
|
7 77.8%
|
8 72.7%
|
4 44.4%
|
6 75.0%
|
4 50.0%
|
38 65.5%
|
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Male |
4 30.8%
|
2 22.2%
|
3 27.3%
|
5 55.6%
|
2 25.0%
|
4 50.0%
|
20 34.5%
|
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||||||
Number Analyzed | 13 participants | 9 participants | 11 participants | 9 participants | 8 participants | 8 participants | 58 participants | |
Hispanic or Latino |
0 0.0%
|
0 0.0%
|
0 0.0%
|
2 22.2%
|
0 0.0%
|
1 12.5%
|
3 5.2%
|
|
Not Hispanic or Latino |
13 100.0%
|
9 100.0%
|
11 100.0%
|
7 77.8%
|
8 100.0%
|
7 87.5%
|
55 94.8%
|
|
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%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||||||
Number Analyzed | 13 participants | 9 participants | 11 participants | 9 participants | 8 participants | 8 participants | 58 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
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%
|
|
Black or African American |
2 15.4%
|
2 22.2%
|
1 9.1%
|
0 0.0%
|
1 12.5%
|
0 0.0%
|
6 10.3%
|
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White |
11 84.6%
|
7 77.8%
|
10 90.9%
|
9 100.0%
|
7 87.5%
|
6 75.0%
|
50 86.2%
|
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More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
2 25.0%
|
2 3.4%
|
|
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%
|
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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United States | Number Analyzed | 13 participants | 9 participants | 11 participants | 9 participants | 8 participants | 8 participants | 58 participants |
13 100.0%
|
9 100.0%
|
11 100.0%
|
9 100.0%
|
8 100.0%
|
8 100.0%
|
58 100.0%
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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: | NCT00801398 |
Other Study ID Numbers: |
EN3203-010 |
First Submitted: | December 2, 2008 |
First Posted: | December 3, 2008 |
Results First Submitted: | December 20, 2018 |
Results First Posted: | February 27, 2019 |
Last Update Posted: | February 27, 2019 |