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