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NCT01442376 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric Patients
A Phase 3 study, sponsored by Helsinn Healthcare.
- Completed
- Registry status
- Phase 3
- Development phase
- 502
- Enrollment target
NCT01442376 is a Phase 3 study that has completed, run by Helsinn Healthcare. The registered enrollment target is 502 participants.
The verdict
NCT01442376, a Phase 3 study, has completed, sponsored by Helsinn Healthcare.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 502 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Ondansetron
- DRUG Palonosetron
- DRUG Placebo to Ondansetron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 502 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01442376
The ClinicalTrials.gov registry entry for NCT01442376 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 502 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 3 interventions - of which Ondansetron is the first listed.
NCT01442376 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01442376 about?
NCT01442376 is a clinical study titled "Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric Patients". 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 ...
What is the current status of trial NCT01442376?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 502 participants. The study started on 2011-09. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01442376?
The interventions under investigation include: Ondansetron (DRUG), Palonosetron (DRUG), Placebo to Ondansetron (DRUG).
Who is sponsoring clinical trial NCT01442376?
This trial is sponsored by Helsinn Healthcare, which has 18 total clinical trials registered on ClinicalTrials.gov.
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