Phase 3
Completed N=58
Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.
Source: ClinicalTrials.gov NCT00801398 ↗Enrolled (actual)
58
Serious AEs
6.9%
Results posted
Feb 2019
Primary outcomePrimary: 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 — -13.4; -22.2; -21.6; -16.7 mm
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
When post-operative parenteral analgesia is discontinued, oral dosing with study medication may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS (pain intensity score greater than or equal to 40).
This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
-13.4; -22.2; -21.6; -16.7; 0.5; -17.4 | — |
| PRIMARY Subjects Taking Rescue Medication |
9; 9; 7; 5; 6; 4 | — |
| SECONDARY AUC(0-t) of Single Dose of Oxymorphone by Treatment Group |
6.395; 3.766; 67.040; 1.544; 3.040; 7.354 | — |
| SECONDARY AUC(0-inf) of Single Dose of Oxymorphone by Treatment Group |
7.632; 10.223; 109.294; 4.987; 8.692; 12.795 | — |
| SECONDARY Cmax of Single Dose of Oxymorphone by Treatment Group |
1.243; 0.828; 5.295; 0.314; 0.487; 0.940 | — |
| SECONDARY Tmax of Single Dose of Oxymorphone by Treatment Group |
4.898; 3.681; 6.193; 3.885; 4.631; 3.785 | — |
| SECONDARY Terminal Rate Constant of Single Dose of Oxymorphone by Treatment Group |
0.209; 0.214; 0.073; 0.281; 0.101; 0.042 | — |
| SECONDARY Terminal Half-life of Single Dose of Oxymorphone by Treatment Group |
12.099; 15.900; 19.974; 19.215; 23.635; 22.520 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female > 12 to 17 years of age, inclusive
- Weigh at least 50 kg
- Postoperative oral opioid analgesia required for at least 24 hours or 48 hours following postoperataive parenteral analgesia
- Are expected to be hospitalized for the duration of the study
Exclusion Criteria
- Known allergy to, or a significant reaction to, oxymorphone or another opioid
- Life expectancy of < 4 weeks
- Positive pregnancy test at screening
Data sourced from ClinicalTrials.gov (NCT00801398). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.