NCT01594749

Efficacy and Safety of Fosaprepitant Dimeglumine in Preventing Chemotherapy-Induced Nausea and Vomiting (MK-0517-031)

A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Efficacy and Safety of a Single 150 mg Dose of Intravenous Fosaprepitant Dimeglumine for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With Moderately Emetogenic Chemotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,015 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to demonstrate that, when given concomitantly with a 5-hydroxytryptamine 3 (5-HT3) antagonist and a corticosteroid, a single 150 mg intravenous (IV) dose of fosaprepitant given on Day 1 is superior to the control regimen of 5-HT3 antagonist and corticosteroid only, in preventing chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC).

Conditions

• Chemotherapy-Induced Nausea and Vomiting (CINV)

Interventions

Type	Name	Description
DRUG	Fosaprepitant dimeglumine
DRUG	Fosaprepitant Placebo
DRUG	Dexamethasone
DRUG	Ondansetron
DRUG	Dexamethasone Placebo
DRUG	Ondansetron Placebo
DRUG	Rescue Therapy

Timeline

• Start date: 2012-09-24
• Primary completion: 2014-11-03
• Completion: 2014-11-03
• First posted: 2012-05-09
• Last updated: 2018-09-04
• Results posted: 2015-09-25