494
Participants
Start Date
December 12, 2012
Primary Completion Date
August 4, 2014
Study Completion Date
August 4, 2014
Aprepitant
Aprepitant (125 mg PO, QD) on Day 1, Aprepitant (80 mg PO, QD) on Days 2 and 3
Aprepitant Placebo
Aprepitant Placebo (PO, QD) on Days 1, 2, and 3
Ondansetron
Ondansetron (16 mg, IV, QD) on Day 1 and/or ondansetron (8 mg PO BID) on Days 2 and 3
Dexamethasone
Dexamethasone (20 mg or 12 mg, PO) on Day 1
Ondansetron Placebo
Ondansetron Placebo (PO, BID) on Days 2 and 3
Rescue Therapy (granisetron, dolasetron, tropisetron or ondansetron; metoclopramide or alizapride).
Use of a rescue therapy for nausea and vomiting is permitted throughout the study. Permitted rescue therapies include a drug from among the following classes: 5-hydroxytryptamine (5-HT3) antagonists (granisetron, dolasetron, tropisetron or ondansetron), benzodiazepines, or benzamides (e.g., metoclopramide or alizapride).
Merck Sharp & Dohme LLC
INDUSTRY