CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,455 enrolled
Drug / intervention
Netupitant and Palonosetron +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01339260
NCT01339260Phase 3Completed

A Phase III Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Study of the Efficacy and Safety of Oral Netupitant Administered in Combination With Palonosetron and Dexamethasone Compared to Oral Palonosetron and Dexamethasone for the Prevention of Nausea and Vomiting in Cancer Patients Receiving Moderately Emetogenic Chemotherapy

Helsinn Healthcare SA·interventional·Posted Apr 20, 2011·Updated Nov 26, 2014

In Brief

A Phase 3 clinical trial evaluating Netupitant and Palonosetron, Palonosetron, and 1 other intervention for Chemotherapy-Induced Nausea and Vomiting. Completed, enrolled 1,455 participants across 172 sites in 15 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Belarus, Brazil, Bulgaria, Croatia, Germany, Hungary, India, Italy, Mexico, Poland, Romania, Russia, Ukraine, United States
CollaboratorsParexel

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 20, 2011
Enrollment StartApr 1, 2011
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 15.2 years ago

Interventions

Netupitant and Palonosetrondrug

Palonosetrondrug

Dexamethasonedrug