A Korean Study of Efficacy and Safety of Aprepitant-based Triple Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in the First Cycle of Moderately Emetogenic Chemotherapy (Non-doxorubicin Hydrochloride [Adriamycin] and Cyclophosphamide Regimens) (MK-0869-225) (KMEC)

PHASE4CompletedINTERVENTIONAL
Enrollment

494

Participants

Timeline

Start Date

December 12, 2012

Primary Completion Date

August 4, 2014

Study Completion Date

August 4, 2014

Conditions
NauseaVomiting
Interventions
DRUG

Aprepitant

Aprepitant (125 mg PO, QD) on Day 1, Aprepitant (80 mg PO, QD) on Days 2 and 3

DRUG

Aprepitant Placebo

Aprepitant Placebo (PO, QD) on Days 1, 2, and 3

DRUG

Ondansetron

Ondansetron (16 mg, IV, QD) on Day 1 and/or ondansetron (8 mg PO BID) on Days 2 and 3

DRUG

Dexamethasone

Dexamethasone (20 mg or 12 mg, PO) on Day 1

DRUG

Ondansetron Placebo

Ondansetron Placebo (PO, BID) on Days 2 and 3

DRUG

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).

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT01636947 - A Korean Study of Efficacy and Safety of Aprepitant-based Triple Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in the First Cycle of Moderately Emetogenic Chemotherapy (Non-doxorubicin Hydrochloride [Adriamycin] and Cyclophosphamide Regimens) (MK-0869-225) (KMEC) | Biotech Hunter | Biotech Hunter