CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,322 enrolled
Drug / intervention
Comparator: fosaprepitant dimeglumine +4 moredrug
Likely dose
Comparator: fosaprepitant dimeglumine 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00619359
NCT00619359Phase 3Completed
CompareCT.gov

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

Merck Sharp & Dohme LLC·interventional·Posted Feb 21, 2008·Updated Mar 21, 2017

In Brief

A Phase 3 clinical trial evaluating Comparator: fosaprepitant dimeglumine, Comparator: Aprepitant, and 2 other interventions for Chemotherapy-Induced Nausea and Vomiting (CINV). Completed, enrolled 2,322 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChemotherapy-Induced Nausea and Vomiting (CINV)
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 21, 2008
Enrollment StartFeb 1, 2008
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.4 years ago

Interventions

Comparator: fosaprepitant dimegluminedrug

single IV dose of 150 mg of fosaprepitant dimeglumine on Day 1.

Comparator: Aprepitantdrug

Aprepitant 3-day dosing oral regimen (125 mg on Day 1 followed by 80 mg on Days 2 and 3).

Dexamethasonedrug

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.

Dexamethasonedrug

Oral dose of 12 mg of dexamethasone on Day 1, and 8 mg on Days 2-4.

Ondansetrondrug

single IV dose of 32 mg of ondansetron on Day 1.