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

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.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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.
Enrollment: 413
Study Start Date: July 2011
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Netupitant and Palonosetron plus dexamethasone
- Active Comparator: Aprepitant and Palonosetron plus dexamethasone