Status:
COMPLETED
A Study of Ramosetron Plus DX, Dexamethasone, Compared to Granisetron Plus DX for the Prevention of Vomiting and Nausea
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Astellas Pharma Taiwan, Inc.
Conditions:
Vomiting
Nausea
Eligibility:
All Genders
20-74 years
Phase:
PHASE3
Brief 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 vomi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
287 Patients enrolled
Trial Details
Trial ID
NCT00272285
Start Date
January 1 2006
End Date
March 1 2008
Last Update
March 9 2017
Active Locations (2)
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1
Tainan, Taiwan
2
Taipei, Taiwan, 105