NCT01376297

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

A Phase III, Multicenter, Randomized, Double-blind, Unbalanced (3:1) Active Control Study to Assess the Safety and Describe the Efficacy of Netupitant and Palonosetron for the Prevention of Chemotherapy-induced Nausea and Vomiting in Repeated Chemotherapy Cycles.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 413 (actual)
• Sponsor: Helsinn Healthcare SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

NETU-10-29 is a clinical study assessing safety of netupitant and palonosetron, two antiemetic drugs, both given with oral dexamethasone. The objective of the study is to evaluate if netupitant and palonosetron are safe when administered to prevent nausea and vomiting after administration of repeated cycles of chemotherapy.

Conditions

• Chemotherapy-Induced Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Netupitant and Palonosetron
DRUG	Aprepitant
DRUG	Palonosetron
DRUG	Dexamethasone

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-09-01
• First posted: 2011-06-20
• Last updated: 2014-11-17
• Results posted: 2014-11-17

Locations

75 sites across 10 countries: United States, Bulgaria, Czechia, Germany, Hungary, India, Poland, Russia, Serbia, Ukraine