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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

287 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Vomiting Nausea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Intravenous (IV)

Group Type EXPERIMENTAL

Ramosetron

Intervention Type DRUG

IV, concomitant administration with dexamethasone

2

Intravenous (IV)

Group Type ACTIVE_COMPARATOR

Granisetron

Intervention Type DRUG

IV, concomitant administration with dexamethasone

Interventions

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Ramosetron

IV, concomitant administration with dexamethasone

Intervention Type DRUG

Granisetron

IV, concomitant administration with dexamethasone

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No