Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01363479 · ClinicalTrials.gov registry record · Phase 3
An Efficacy and Safety Study of Oral and Intravenous Palonosetron for the Prevention of Nausea and Vomiting
A Phase 3 study, sponsored by Helsinn Healthcare.
- Completed
- Registry status
- Phase 3
- Development phase
- 743
- Enrollment target
NCT01363479 is a Phase 3 study that has completed, run by Helsinn Healthcare. The registered enrollment target is 743 participants.
The verdict
NCT01363479, a Phase 3 study, has completed, sponsored by Helsinn Healthcare.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 743 participants
- Enrollment target
Study Summary
PALO-10-01 is a clinical study assessing efficacy and safety of a single oral dose of palonosetron compared to a single intravenous dose of palonosetron (Aloxi, an antiemetic drug), both given with oral dexamethasone. The objective of the study is to demonstrate that oral palonosetron 0.50 mg is as effective as (non-inferior to) palonosetron IV 0.25 mg to prevent nausea and vomiting induced by highly emetogenic cancer chemotherapy in the 0-24 hours after administration of a single cycle of highly emetogenic chemotherapy.
Interventions
- DRUG Dexamethasone
- DRUG Oral palonosetron
- DRUG I.V. palonosetron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 743 participants |
| Start Date | 2011-07 |
| Est. Completion | 2012-11 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01363479
The ClinicalTrials.gov registry entry for NCT01363479 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 743 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 Dexamethasone is the first listed.
NCT01363479 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01363479 about?
NCT01363479 is a clinical study titled "An Efficacy and Safety Study of Oral and Intravenous Palonosetron for the Prevention of Nausea and Vomiting". PALO-10-01 is a clinical study assessing efficacy and safety of a single oral dose of palonosetron compared to a single intravenous dose of palonosetron (Aloxi, an antiemetic drug), both given with oral dexamethasone. The objective of the study is to demonstrate that oral palonosetron 0.50 mg is as ...
What is the current status of trial NCT01363479?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 743 participants. The study started on 2011-07. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01363479?
The interventions under investigation include: Dexamethasone (DRUG), Oral palonosetron (DRUG), I.V. palonosetron (DRUG).
Who is sponsoring clinical trial NCT01363479?
This trial is sponsored by Helsinn Healthcare, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.