NCT00431236

A Study of the Drug Casopitant for the Prevention of Nausea Caused By Cisplatin-Based Highly Emetogenic Chemotherapy

A Phase III Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group Study of the Efficacy and Safety of the Intravenous and Oral Formulations of the Neurokinin-1 Receptor Antagonist, Casopitant, Administered in Combination With ZOFRAN and Dexamethasone for Prevention of Chemotherapy-Induced Nausea and Vomiting in Cancer Subjects Receiving Highly Emetogenic Cisplatin-Based Chemotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 810 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase III trial designed to demonstrate that casopitant when added to dexamethasone and ondansetron is more effective in the prevention of vomiting then dexamethasone and ondansetron alone, in patients who receive a cisplatin-based highly emetogenic chemotherapy.

Detailed description

A Phase III Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group Study of the Efficacy and Safety of the Intravenous and Oral Formulations of the Neurokinin-1 Receptor Antagonist, Casopitant, administered in Combination with ZOFRAN and Dexamethasone for Prevention of Chemotherapy-Induced Nausea and Vomiting in Cancer Subjects Receiving Highly Emetogenic Cisplatin-Based Chemotherapy

Conditions

• Nausea and Vomiting, Chemotherapy-Induced

Interventions

Type	Name	Description
DRUG	Oral Casopitant (GW679769)
DRUG	IV Casopitant (GW679769)
DRUG	IV ondansetron hydrochloride
DRUG	Oral dexamethasone

Timeline

• Start date: 2006-11-06
• Primary completion: 2007-10-09
• Completion: 2007-10-09
• First posted: 2007-02-05
• Last updated: 2017-08-22

Locations

80 sites across 22 countries: Argentina, Belgium, Bulgaria, Croatia, Czechia, Finland, Greece, Hungary, India, Ireland, Italy, Malaysia, Pakistan, Philippines, Poland, Romania, Slovakia, South Korea, Spain, Taiwan, Thailand, Ukraine