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Completed Phase 3 Interventional Results available

Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric Patients

ClinicalTrials.gov ID: NCT01442376

Public ClinicalTrials.gov record NCT01442376. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 12:21 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Two Different Doses of Palonosetron Compared to Ondansetron in the Prevention of CINV in Pediatric Patients Undergoing Single and Repeated Cycles of MEC or HEC

Study identification

NCT ID
NCT01442376
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Helsinn Healthcare SA
Industry
Enrollment
502 participants

Conditions and interventions

Interventions

  • Palonosetron Drug
  • Ondansetron Drug
  • Placebo to Ondansetron Drug
  • Placebo to Palonosetron Drug

Drug

Eligibility (public fields only)

Age range
Up to 16 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 31, 2011
Primary completion
Sep 30, 2012
Completion
Oct 31, 2012
Last update posted
Aug 6, 2014

2011 – 2012

United States locations

U.S. sites
14
U.S. states
11
U.S. cities
14
Facility City State ZIP Site status
Arkansas Children's Hospital Little Rock Arkansas 72202
City of Hope National Medical Center Duarte California 91010
The Children's Hospital Aurora Colorado 80045
A. I. duPont Hospital for Children Wilmington Delaware 19803
Nemours Children's Clinic Jacksonville Florida 32207
Nemours Children's Clinic-Orlando Orlando Florida 32806
Nemours Children's Clinic Pensacola Florida 32504
Backus Children's Hospital at University Pediatrics Savannah Georgia 31404
University of Kentucky - Chandler Medical Center Lexington Kentucky 40536
Upstate Medical University Syracuse New York 13210
Department of Pediatrics Valhalla New York 10595
Nationwide Children's Hospital Columbus Ohio 43205
Medical University of South Carolina Charleston South Carolina 29425
Cook Children's Medical Center Fort Worth Texas 76104

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 53 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01442376, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 6, 2014 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01442376 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →