A Study of Ramosetron Plus DX, Dexamethasone, Compared to Granisetron Plus DX for the Prevention of Vomiting and Nausea

A Double-blind, Randomized, Parallel, Comparative Study to Evaluate the Efficacy and Safety of Ramosetron Plus Dexamethasone Injection for the Prevention of Chemotherapy-Induced Vomiting and Nausea

The purpose of this study is to compare the efficacy and safety of ramosetron plus dexamethasone injection with granisetron plus dexamethasone injection for the prevention of chemotherapy-induced vomiting and nausea.

Inclusion Criteria:

• Subject with age between 20-74 years old (inclusive) of either sex
• Cancer subject is scheduled to receive the designated chemotherapy programs
• Subject without symptoms of vomiting for at least one week before dosing trial medication
• Subject with ECOG performance status scale no greater than 2
• Subject has signed the written informed consent form

Exclusion Criteria:

• Subject has received radiotherapy to the abdomen or pelvis within 4 weeks before entering this study
• Subject has received the designated chemotherapy programs within 6 months before entering the study
• Subject has known heart failure or myocardial infraction or with laboratory abnormalities at screening
• Subject has known concurrent diseases that may cause vomiting
• Subject has taken medications that could influence the outcome of the study within 3 days before entering the study
• Subject with a history of allergy or intolerance to ramosetron, granisetron or dexamethasone
• Female subject who is pregnant or breastfeeding
• Subject with life expectancy less than 3 months
• Subject participated other investigational drug trial within 1 month before entering this study