Completed PHASE3 INTERVENTIONAL 2-arm NCT01395901

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

A Multicenter, Double-blind, Double-dummy, Randomized, Parallel Group, Stratified Study to Evaluate the Efficacy and Safety of a Single IV Dose of Palonosetron Compared to a Single IV Dose of Ondansetron to Prevent Postoperative Nausea and Vomiting in Pediatric Patients.

Sponsor: Helsinn Healthcare SA

Conditions Postoperative Nausea and Vomiting

Interventions Ondansetron Palonosetron Placebo to Ondansetron Placebo to Palonosetron

Updated 7 times since 2017 Last updated: Jul 29, 2014 Started: Jun 30, 2011 Primary completion: Mar 31, 2012 Completion: Apr 30, 2012

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Postoperative Nausea and Vomiting, this trial is completed. The trial is conducted by Helsinn Healthcare SA and has accumulated 7 data snapshots since 2011. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

7 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Jun 2011

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Helsinn Healthcare SA

Data source: Helsinn Healthcare SA

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Arkhangelsk, Russia , Brno, Czechia , Budapest, Hungary , Buenos Aires, Argentina , Camden, United States , Chapel Hill, United States , Cincinnati, United States , Dnipropetrovsk, Ukraine , Donetsk, Ukraine , Dunaújváros, Hungary and 29 more locations