Conditions: Post-Operative Pain Acute Pain
Keywords: Surgical Pain Acute Post-Surgical Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 28
Healthy volunteers: no

Brief summary:
The purpose of the study is to evaluate the efficacy, tolerability, safety and pharmacokinetics of Oxymorphone HCl as an analgesic for acute moderate to severe post-operative pain in pediatric subjects.

Detailed description:

Arms:
arm 1: Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase. arm 2: Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; placebo controlled, randomized, double-blinded multiple-dose phase. arm 3: Sodium Chloride 0.9% solution; comparator for multiple-dose phase.

Interventions: intervention 1: Oxymorphone HCl intervention 2: Placebo
Intervention descriptions: intervention 1: Oral liquid and injection; dose to be determined by Independent Data Monitoring Committee (IDMC). intervention 2: Placebo Comparator for the double-blinded, placebo-controlled multiple-dose phase.

Protocol document:
Prot_000.pdf: 
This study was initiated at the request of the FDA as a class required Post-marketing Study in 
Pediatric Patients.



















































































































































































































SAP_001.pdf: 
This study was conducted at the request of the FDA as a class required Post Marketing
Study in pediatric patients.