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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00272285

Collaborator

Astellas Pharma Taiwan, Inc. (Industry)

287

Enrollment

Locations

Arms

Duration (Months)

143.5

Patients Per Site

5.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vomiting Nausea	Drug: Ramosetron Drug: Granisetron	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

287 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Intravenous (IV)	Drug: Ramosetron IV, concomitant administration with dexamethasone
Active Comparator: 2 Intravenous (IV)	Drug: Granisetron IV, concomitant administration with dexamethasone

Arm

Intervention/Treatment

Experimental: 1

Intravenous (IV)

Drug: Ramosetron

IV, concomitant administration with dexamethasone

Active Comparator: 2

Intravenous (IV)

Drug: Granisetron

IV, concomitant administration with dexamethasone

Outcome Measures

Primary Outcome Measures

Proportion of patients without vomiting after the start of chemotherapy for 24 hours [1 Day]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 74 Years

Sexes Eligible for Study:

All

Accepts 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