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

NCT00619359 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2322

Last updated 2017-03-21

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-06-30
Completion
2009-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00619359 on ClinicalTrials.gov