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NCT01339260 · ClinicalTrials.gov registry record · Phase 3

An Efficacy and Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting

A Phase 3 study, sponsored by Helsinn Healthcare.

Completed
Registry status
Phase 3
Development phase
1,455
Enrollment target

NCT01339260 is a Phase 3 study that has completed, run by Helsinn Healthcare. The registered enrollment target is 1,455 participants.

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The verdict

NCT01339260, a Phase 3 study, has completed, sponsored by Helsinn Healthcare.

COMPLETED
Registry status
Phase 3
Development phase
1,455 participants
Enrollment target

Study Summary

NETU-08-18 is a two-arm clinical study assessing efficacy and safety of a single oral dose of netupitant and palonosetron, two antiemetic drugs, versus oral palonosetron, both given with oral dexamethasone. The objective of the study is to demonstrate that netupitant and palonosetron are more effective than palonosetron alone, to prevent nausea and vomiting induced by moderately emetogenic cancer chemotherapy after administration of repeated cycles of chemotherapy.

Interventions

  • DRUG Dexamethasone
  • DRUG Palonosetron
  • DRUG Netupitant and Palonosetron

Trial Details

FieldValue
Enrollment Target 1,455 participants
Start Date 2011-04
Phase Phase 3

Sponsor

Helsinn Healthcare

18 total trials

What the Registry Record Tells You About NCT01339260

The ClinicalTrials.gov registry entry for NCT01339260 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,455 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.

NCT01339260 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01339260 about?

NCT01339260 is a clinical study titled "An Efficacy and Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting". NETU-08-18 is a two-arm clinical study assessing efficacy and safety of a single oral dose of netupitant and palonosetron, two antiemetic drugs, versus oral palonosetron, both given with oral dexamethasone. The objective of the study is to demonstrate that netupitant and palonosetron are more effect...

What is the current status of trial NCT01339260?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,455 participants. The study started on 2011-04.

What interventions are being tested in trial NCT01339260?

The interventions under investigation include: Dexamethasone (DRUG), Palonosetron (DRUG), Netupitant and Palonosetron (DRUG).

Who is sponsoring clinical trial NCT01339260?

This trial is sponsored by Helsinn Healthcare, which has 18 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.