At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Moderately Emetogenic Chemotherapy (MEC)
In Brief
A Phase 3 clinical trial evaluating aprepitant, Comparator: ondansetron, and 3 other interventions for Chemotherapy-Induced Nausea and Vomiting. Completed, enrolled 848 participants.
Detailed Summary
The study will test aprepitant for the prevention of CINV in patients receiving their initial cycle of Moderately Emetogenic Chemotherapy (MEC). Patients receiving more then one cycle of chemotherapy may opt to participate in an optional second cycle during which the patient will receive the same antiemetic regimen as cycle 1, except that an IV formulation of aprepitant will be given in place of the oral formulation on study day one. Study drug administration on subsequent days will be given orally as in cycle 1.
Study Details
Timeline
Interventions
aprepitant 125 mg capsule; aprepitant 80 mg capsule Three day treatment period.
Ondansetron 8 mg capsule Three day treatment period.
dexamethasone 12 mg tablets; 20 mg tablets Three day treatment period.
fosaprepitant dimeglumine 115 mg
dexamethasone 12mg Pbo tablets.
Aprepitant 80 mg \& 125 mg Pbo capsules.