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

Study Overview
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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.

Official Title
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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

Conditions
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Vomiting, Nausea

Intervention / Treatment
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* Drug: Ramosetron
* Drug: Granisetron


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Intravenous (IV) | Drug: Ramosetron<br>* IV, concomitant administration with dexamethasone<br>|
| Active Comparator: 2<br>Intravenous (IV) | Drug: Granisetron<br>* IV, concomitant administration with dexamethasone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients without vomiting after the start of chemotherapy for 24 hours |  | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Serotonin antagonists, Randomized controlled trial, Combination drug therapy, Double-blind method