NCT00619359

Evaluation of Fosaprepitant (MK0517) in Single Dose Schedule (0517-017)

A Phase III, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of a Single Dose of Intravenous MK-0517 for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With Cisplatin Chemotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,322 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the safety, tolerability, and efficacy of MK0517 to prevent Chemotherapy-Induced Nausea and Vomiting (CINV) associated with Cisplatin chemotherapy.

Conditions

• Chemotherapy-Induced Nausea and Vomiting (CINV)

Interventions

Type	Name	Description
DRUG	Comparator: fosaprepitant dimeglumine	single IV dose of 150 mg of fosaprepitant dimeglumine on Day 1.
DRUG	Comparator: Aprepitant	Aprepitant 3-day dosing oral regimen (125 mg on Day 1 followed by 80 mg on Days 2 and 3).
DRUG	Dexamethasone	Oral dose of 12 mg of dexamethasone on Day 1, 8 mg on Day 2, and 8 mg twice a day on Days 3-4.
DRUG	Dexamethasone	Oral dose of 12 mg of dexamethasone on Day 1, and 8 mg on Days 2-4.
DRUG	Ondansetron	single IV dose of 32 mg of ondansetron on Day 1.

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2008-02-21
• Last updated: 2017-03-21
• Results posted: 2010-02-12