Overview

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

Status:
Completed
Trial end date:
2008-03-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Astellas Pharma Inc
Collaborator:
Astellas Pharma Taiwan, Inc.
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Granisetron
Ramosetron
Criteria
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