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

NCT01395901 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 670

Last updated 2014-07-30

Study results available
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Summary

The primary objective of this study is to evaluate the efficacy of a single palonosetron IV dose compared to a single ondansetron IV dose in the prevention of postoperative nausea and vomiting through 24 hours after surgery in children aged from neonates up to less than 17 years undergoing elective surgical procedures requiring general intravenous anesthesia. The secondary objective is to evaluate the safety and tolerability of IV palonosetron in pediatric patients.

Conditions

  • Postoperative Nausea and Vomiting

Interventions

DRUG

Palonosetron

Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)

DRUG

Ondansetron

Single dose Ondansetron IV: * 0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for \>40 kg; * 13 years to less than 17 years dose: 4 mg

DRUG

Placebo to Ondansetron

DRUG

Placebo to Palonosetron

Sponsors & Collaborators

  • Helsinn Healthcare SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-03-31
Completion
2012-04-30

Countries

  • United States
  • Argentina
  • Czechia
  • Hungary
  • Poland
  • Puerto Rico
  • Russia
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01395901 on ClinicalTrials.gov