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

Astellas

Status and phase

Completed

Phase 3

Conditions

Vomiting

Nausea

Treatments

Drug: Granisetron

Drug: Ramosetron

Study type

Interventional

Funder types

Industry

Identifiers

NCT00272285

06003/TnIO01

Details and patient eligibility

About

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.

Enrollment

287 patients

Sex

All

Ages

20 to 74 years old

Volunteers

No Healthy Volunteers

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