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

Astellas Pharma Inc0 sites287 target enrollmentJanuary 2006

ConditionsVomiting Nausea

InterventionsGranisetron Ramosetron

DrugsRamosetron Granisetron

Overview

Phase: Phase 3
Intervention: Granisetron
Conditions: Vomiting
Sponsor: Astellas Pharma Inc
Enrollment: 287
Primary Endpoint: Proportion of patients without vomiting after the start of chemotherapy for 24 hours
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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 vomiting and nausea.

Registry

clinicaltrials.gov

Start Date

January 2006

End Date

March 2008

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Astellas Pharma Inc

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

2

Intravenous (IV)

Intervention: Granisetron

1

Intravenous (IV)

Intervention: Ramosetron

Outcomes

Primary Outcomes

Proportion of patients without vomiting after the start of chemotherapy for 24 hours

Time Frame: 1 Day

Secondary Outcomes

Response rate of vomiting prevention(1 Day)
The nausea degree evaluated by patient's 10-cm visual analogue scale (VAS)(1 Day)
The number of vomiting episodes(1 Day)