Trial · NCT00801398
Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.
NCT00801398, Phase 3, Completed, Endo USA Inc., a Keenova Therapeutics Company; results first posted 2019-02-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects. Trials, record NCT00801398. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00801398
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.
- NCT number
- NCT00801398
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 58 participants, actual
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Conditions
- Postoperative Pain
- Interventions
- Oxymorphone IR
- First posted
- 2008-12-03
- Last updated
- 2019-02-27
- Results first posted
- 2019-02-27
- 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.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet | Single Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h or Rescue; Multiple Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h, subsequent doses every 4-6 hours (Multiple Dose #1-11), and Early Termination | Change from Baseline in 100-mm Visual Analog Scales (VAS) in Multiple Dose of Oxymorphone IR Tablet |
| Primary | Subjects Taking Rescue Medication | first dose through 48 hours after first dose | Percentages are based on the number of subjects in each treatment group. |
| Secondary | AUC(0-t) of Single Dose of Oxymorphone by Treatment Group | Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h | AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Ct), calculated by linear trapezoidal rule |
| Secondary | AUC(0-inf) of Single Dose of Oxymorphone by Treatment Group | Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h | AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Ct/terminal rate constant (single-dose period only), where Ct is the concentration at the time of the last quantifiable concentration |
| Secondary | Cmax of Single Dose of Oxymorphone by Treatment Group | Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h | Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval |
| Secondary | Tmax of Single Dose of Oxymorphone by Treatment Group | Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h | Tmax: The time at which Cmax was observed |
| Secondary | Terminal Rate Constant of Single Dose of Oxymorphone by Treatment Group | Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h | λ: Terminal rate constant, calculated as the negative slope of the ln-linear portion of the terminal plasma concentration-time curve (single-dose period only) |
| Secondary | Terminal Half-life of Single Dose of Oxymorphone by Treatment Group | Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h | t½: Terminal half-life, calculated as terminal rate constant/(ln 2) (single-dose period only) |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet | Single Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h or Rescue; Multiple Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h, subsequent doses every 4-6 hours (Multiple Dose #1-11), and Early Termination | ITT Population | mm | MEAN |
| PRIMARY | Subjects Taking Rescue Medication | first dose through 48 hours after first dose | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | AUC(0-t) of Single Dose of Oxymorphone by Treatment Group | Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h | PK Population (only including subjects with sufficient evaluable time points for this outcome measure). | ng*hr/mL | MEAN |
| SECONDARY | AUC(0-inf) of Single Dose of Oxymorphone by Treatment Group | Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h | PK Population (only including subjects with sufficient evaluable time points for this outcome measure). | ng*hr/mL | MEAN |
| SECONDARY | Cmax of Single Dose of Oxymorphone by Treatment Group | Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h | PK Population (only including subjects with sufficient evaluable time points for this outcome measure). | ng/mL | MEAN |
| SECONDARY | Tmax of Single Dose of Oxymorphone by Treatment Group | Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h | PK Population (only including subjects with sufficient evaluable time points for this outcome measure). | hour | MEAN |
| SECONDARY | Terminal Rate Constant of Single Dose of Oxymorphone by Treatment Group | Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h | PK Population (only including subjects with sufficient evaluable time points for this outcome measure). | Time -1 | MEAN |
| SECONDARY | Terminal Half-life of Single Dose of Oxymorphone by Treatment Group | Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h | PK Population (only including subjects with sufficient evaluable time points for this outcome measure). | hour | MEAN |
Source ClinicalTrials.gov
Results by group117
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet | Change From Baseline Single Dose of Oxymorphone IR: 5mg Tablet | 15 Minutes Post Dose/ 15 Minutes Post First Dose | -13.4 | Standard Deviation 22.86 | mm |
| Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet | Change From Baseline Single Dose Oxymorphone IR: 10mg Tablet | 15 Minutes Post Dose/ 15 Minutes Post First Dose | -22.2 | Standard Deviation 17.79 | mm |
| Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet | Change From Baseline Single Dose Oxymorphone IR: 15mg Tablet | 15 Minutes Post Dose/ 15 Minutes Post First Dose | -21.6 | Standard Deviation 13.59 | mm |
| Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet | Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet | 15 Minutes Post Dose/ 15 Minutes Post First Dose | -16.7 | Standard Deviation 23.31 | mm |
| Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet | Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet | 15 Minutes Post Dose/ 15 Minutes Post First Dose | 0.5 | Standard Deviation 9.56 | mm |
| Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet | Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet | 15 Minutes Post Dose/ 15 Minutes Post First Dose | -17.4 | Standard Deviation 13.46 | mm |
| Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet | Change From Baseline Single Dose of Oxymorphone IR: 5mg Tablet | 30 Minutes Post Dose/30 Minutes Post First Dose | -12.8 | Standard Deviation 36.90 | mm |
| Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet | Change From Baseline Single Dose Oxymorphone IR: 10mg Tablet | 30 Minutes Post Dose/30 Minutes Post First Dose | -13.7 | Standard Deviation 28.32 | mm |
| Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet | Change From Baseline Single Dose Oxymorphone IR: 15mg Tablet | 30 Minutes Post Dose/30 Minutes Post First Dose | -22.9 | Standard Deviation 19.87 | mm |
| Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet | Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet | 30 Minutes Post Dose/30 Minutes Post First Dose | -18.3 | Standard Deviation 25.84 | mm |
1 to 10 of 117Source ClinicalTrials.gov
See all 117 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Single Dose of Oxymorphone IR: 5mg Tablet | 13 | |
| Overall Study | STARTED | Single Dose of Oxymorphone IR: 10mg Tablet | 9 | |
| Overall Study | STARTED | Single Dose of Oxymorphone IR: 15mg Tablet | 11 | |
| Overall Study | STARTED | Multiple Dose of Oxymorphone: 5mg Tablet | 9 | |
| Overall Study | STARTED | Multiple Dose of Oxymorphone IR: 10mg Tablet | 8 | |
| Overall Study | STARTED | Multiple Dose of Oxymorphone IR: 15mg Tablet | 8 | |
| Overall Study | COMPLETED | Single Dose of Oxymorphone IR: 5mg Tablet | 7 | |
| Overall Study | COMPLETED | Single Dose of Oxymorphone IR: 10mg Tablet | 0 | |
| Overall Study | COMPLETED | Single Dose of Oxymorphone IR: 15mg Tablet | 4 | |
| Overall Study | COMPLETED | Multiple Dose of Oxymorphone: 5mg Tablet | 3 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events162
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Single Dose of Oxymorphone IR: 5mg Tablet | 0 | 13 | |
| other | Anaemia | Blood and lymphatic system disorders | Single Dose of Oxymorphone IR: 10mg Tablet | 0 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | Single Dose of Oxymorphone IR: 15mg Tablet | 0 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | Multiple Dose of Oxymorphone IR: 5mg Tablet | 1 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | Multiple Dose of Oxymorphone IR: 10mg Tablet | 0 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | Multiple Dose of Oxymorphone IR: 15mg Tablet | 3 | 8 | |
| other | Tachycardia | Cardiac disorders | Single Dose of Oxymorphone IR: 5mg Tablet | 1 | 13 | |
| other | Tachycardia | Cardiac disorders | Single Dose of Oxymorphone IR: 10mg Tablet | 0 | 9 | |
| other | Tachycardia | Cardiac disorders | Single Dose of Oxymorphone IR: 15mg Tablet | 0 | 11 | |
| other | Tachycardia | Cardiac disorders | Multiple Dose of Oxymorphone IR: 5mg Tablet | 1 | 9 |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Single Dose of Oxymorphone IR: 5mg Tablet | 0 | 13 |
| Total, all-cause mortality | Single Dose of Oxymorphone IR: 10mg Tablet | 0 | 9 |
| Total, all-cause mortality | Single Dose of Oxymorphone IR: 15mg Tablet | 0 | 11 |
| Total, all-cause mortality | Multiple Dose of Oxymorphone IR: 5mg Tablet | 0 | 9 |
| Total, all-cause mortality | Multiple Dose of Oxymorphone IR: 10mg Tablet | 0 | 8 |
| Total, all-cause mortality | Multiple Dose of Oxymorphone IR: 15mg Tablet | 0 | 8 |
| Total, other adverse events | Single Dose of Oxymorphone IR: 5mg Tablet | 3 | 13 |
| Total, other adverse events | Single Dose of Oxymorphone IR: 10mg Tablet | 4 | 9 |
| Total, other adverse events | Single Dose of Oxymorphone IR: 15mg Tablet | 7 | 11 |
| Total, other adverse events | Multiple Dose of Oxymorphone IR: 5mg Tablet | 8 | 9 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00801398
GET https://conductscience.org/api/trials/v1/NCT00801398/results?page=2