NCT02517021

A Safety Study of Intravenous Pro-Netupitant and Palonosetron Combination for the Prevention of Nausea and Vomiting

A Phase 3, Multicenter, Randomized, Double-blind, Active Control Study to Evaluate the Safety and Efficacy of IV Pro-netupitant/Palonosetron (260 mg/0.25 mg) Combination for the Prevention of Chemotherapy-induced Nausea and Vomiting in Repeated Chemotherapy Cycles in Patients Receiving Highly Emetogenic Chemotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 405 (actual)
• Sponsor: Helsinn Healthcare SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

NEPA-15-18 is a clinical study assessing safety of pro-netupitant and palonosetron, two antiemetic drugs, given with oral dexamethasone. The objective of the study is to evaluate if pro-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	Pro-netupitant/Palonosetron
DRUG	Netupitant/Palonosetron
DRUG	Dexamethasone

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2015-08-06
• Last updated: 2018-06-20
• Results posted: 2018-06-20

Locations

74 sites across 12 countries: United States, Austria, Croatia, Czechia, Germany, Israel, Italy, Poland, Serbia, South Africa, Spain, Ukraine