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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 is a Phase 3 study that has completed, run by Helsinn Healthcare. The registered enrollment target is 670 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01395901
The ClinicalTrials.gov registry entry for NCT01395901 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 670 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Helsinn Healthcare, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Ondansetron is the first listed.
NCT01395901 reports 0 study locations.
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.
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