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NCT01395901 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
A Phase 3 study, sponsored by Helsinn Healthcare.
- Completed
- Registry status
- Phase 3
- Development phase
- 670
- Enrollment target
NCT01395901: Completed Phase 3 study, sponsored by Helsinn Healthcare.
NCT01395901 is a Phase 3 study that has completed, run by Helsinn Healthcare. The registered enrollment target is 670 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01395901, a Phase 3 study, has completed, sponsored by Helsinn Healthcare.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 670 participants
- Enrollment target
Study 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.
Primary Outcome
Complete Response was defined as no vomiting, no retching, and no use of antiemetic rescue medication during the first 24 hours postoperatively, starting at T0. Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.
Interventions
- DRUG Ondansetron
- DRUG Palonosetron
- DRUG Placebo to Ondansetron
- DRUG Placebo to Palonosetron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 670 participants |
| Start Date | 2011-06 |
| Est. Completion | 2012-04 |
| Phase | Phase 3 |
What the finished NCT01395901 record still lists
NCT01395901 is an interventional study that assigns participants to a tested intervention. The registered 670 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 4 interventions - of which Ondansetron is the first listed.
NCT01395901 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01395901 about?
NCT01395901 is a clinical study titled "Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients". 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 ...
What is the current status of trial NCT01395901?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 670 participants. The study started on 2011-06. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01395901?
The interventions under investigation include: Ondansetron (DRUG), Palonosetron (DRUG), Placebo to Ondansetron (DRUG), Placebo to Palonosetron (DRUG).
Who is sponsoring clinical trial NCT01395901?
This trial is sponsored by Helsinn Healthcare, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01395901's enrollment target sits among peer trials
670 546th of 2000 higher than 1,454 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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