At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,015 enrolled
Drug / intervention
Fosaprepitant dimeglumine +6 moredrug
Likely dose
Not stated in 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.
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
In Brief
A Phase 3 clinical trial evaluating Fosaprepitant dimeglumine, Fosaprepitant Placebo, and 5 other interventions for Chemotherapy-Induced Nausea and Vomiting (CINV). Completed, enrolled 1,015 participants.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
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Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 2012
Enrollment StartSep 2012
Primary CompletionNov 2014
TodayJul 2026
First PostedMay 9, 2012
Enrollment StartSep 24, 2012
Primary CompletionNov 3, 2014
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 14.1 years ago
Interventions
Fosaprepitant dimegluminedrug
Fosaprepitant Placebodrug
Dexamethasonedrug
Ondansetrondrug
Dexamethasone Placebodrug
Ondansetron Placebodrug
Rescue Therapydrug