At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 150 enrolled
Drug / intervention
palonosetron +1 moredrug
Likely dose
palonosetron 1 mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Double-blind, Randomized, Parallel Group, Stratified Study to Assess the Safety and Efficacy of Single IV Doses of Palonosetron to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
In Brief
A Phase 3 clinical trial evaluating palonosetron for Postoperative Nausea and Vomiting. Completed, enrolled 150 participants across 13 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Nausea and Vomiting
CountriesRussia, Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2008
Primary CompletionDec 2008
Study CompletionJan 2009
First PostedJan 2009
TodayJul 2026
First PostedJan 23, 2009
Enrollment StartAug 1, 2008
Primary CompletionDec 1, 2008
Study CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 17.4 years ago
Interventions
palonosetrondrug
palonosetron IV 1 mcg/kg
palonosetrondrug
palonosetron 3mcg/kg IV