Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
Public ClinicalTrials.gov record NCT01395901. 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, 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.
Study identification
- NCT ID
- NCT01395901
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Helsinn Healthcare SA
- Industry
- Enrollment
- 670 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
- May 31, 2011
- Primary completion
- Feb 29, 2012
- Completion
- Mar 31, 2012
- Last update posted
- Jul 29, 2014
2011 – 2012
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Shoals Clinical Research Associates | Florence | Alabama | 35630 | — |
| Shoals Medical Research, LLC | Sheffield | Alabama | 35660 | — |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| Bascom Palmer Eye Institute - University of Miami | Miami | Florida | 33136 | — |
| Louisiana State University Health Sciences Center | Shreveport | Louisiana | 71103 | — |
| CRC of Jackson | Jackson | Mississippi | 39202 | — |
| Cooper University Hospital | Camden | New Jersey | 08103 | — |
| The University of North Carolina Hospitals | Chapel Hill | North Carolina | 27599 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Clinical Trial Developers | Cincinnati | Ohio | 45255 | — |
| Texas Orthopedic Specialist, P.A | Grapevine | Texas | 76051 | — |
| Memorial Hermann Hospital | Houston | Texas | 77030 | — |
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 32 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01395901, 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 Jul 29, 2014 · Synced Jul 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01395901 live on ClinicalTrials.gov.