Phase 3 N=58 Treatment

Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.

Postoperative Pain

Bottom Line

View on ClinicalTrials.gov: NCT00801398 ↗

Enrolled (actual)

Serious AEs

6.9%

Results posted

Feb 2019

Primary outcome: 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 mm

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Oxymorphone IR (Drug)
Age: Pediatric · 12+ yrs
Sex: All
Sponsor: Endo Pharmaceuticals
Primary completion: Apr 2011

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	—

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.

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

View full record on ClinicalTrials.gov →

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.