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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: Completed Phase 3 study, sponsored by Helsinn Healthcare.
NCT01363479 is a Phase 3 study that has completed, run by Helsinn Healthcare. The registered enrollment target is 743 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01363479 record still lists
NCT01363479 is an interventional study that assigns participants to a tested intervention. The registered 743 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.
NCT01363479 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT01363479's enrollment target sits among peer trials
743 476th of 2000 higher than 1,525 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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