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

Phase 3

Completed

• Conditions: Vomiting; Nausea
• Interventions: Drug: Ramosetron; Drug: Granisetron

• Registration Number: NCT00272285
• Lead Sponsor: Astellas Pharma Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-03
• Study First Submitted QC: 2006-01-03
• Study First Posted: 2006-01-05
• Primary Completion: 2007-12
• Study Completion: 2008-03
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-07
• Last Update Posted: 2017-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 287

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Ramosetron	Intravenous (IV)
2	Granisetron	Intravenous (IV)

Primary Outcome Measures

Name	Time	Method
Proportion of patients without vomiting after the start of chemotherapy for 24 hours	1 Day

Secondary Outcome Measures

Name	Time	Method
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