Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric Patients
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective is to evaluate the efficacy of two different doses of IV palonosetron in the prevention of chemotherapy induced nausea and vomiting in MEC and HEC patients through 120 hours after start of chemotherapy in single and repeated chemotherapy cycles. The secondary objectives are to evaluate the safety and tolerability of IV palonosetron in pediatric patients and evaluate the pharmacokinetics of IV palonosetron in a subset of pediatric CINV patients.
Study identification
- NCT ID
- NCT01442376
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 502 participants
Conditions and interventions
Conditions
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
- Sep 2011 (Type not available)
- Primary completion
- Oct 2012 (Actual)
- Completion
- Nov 2012 (Actual)
- Last update posted
- Aug 7, 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 7, 2014 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01442376 live on ClinicalTrials.gov.