drugset / Trial / NCT00828295

Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients

NCT00828295

Phase 3 Completed 150 enrolled Helsinn Healthcare SA
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The objective of the study is to assess the safety and efficacy of two doses of IV palonosetron each administered as a single dose for the prevention of postoperative nausea and vomiting through 72 hours postoperatively in children aged 28 days up to 16 years inclusive undergoing surgical procedures requiring general endotracheal inhalation anesthesia.

Timeline

Start
2008-08
Primary completion
2008-12
Completion
2009-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Palonosetron Other / unclassified 1 ug/kg Intravenous
Subject Palonosetron Other / unclassified 3 ug/kg Intravenous

Indications

No indication recorded.