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

Primary Purpose

Vomiting, Nausea

Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Ramosetron
Granisetron
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vomiting focused on measuring Serotonin antagonists, Randomized controlled trial, Combination drug therapy, Double-blind method

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Intravenous (IV)

Intravenous (IV)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 3, 2006
Last Updated
March 7, 2017
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Taiwan, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00272285
Brief Title
A Study of Ramosetron Plus DX, Dexamethasone, Compared to Granisetron Plus DX for the Prevention of Vomiting and Nausea
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 Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Taiwan, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vomiting, Nausea
Keywords
Serotonin antagonists, Randomized controlled trial, Combination drug therapy, Double-blind method

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
287 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Intravenous (IV)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Intravenous (IV)
Intervention Type
Drug
Intervention Name(s)
Ramosetron
Intervention Description
IV, concomitant administration with dexamethasone
Intervention Type
Drug
Intervention Name(s)
Granisetron
Intervention Description
IV, concomitant administration with dexamethasone
Primary Outcome Measure Information:
Title
Proportion of patients without vomiting after the start of chemotherapy for 24 hours
Time Frame
1 Day
Secondary Outcome Measure Information:
Title
Response rate of vomiting prevention
Time Frame
1 Day
Title
The number of vomiting episodes
Time Frame
1 Day
Title
The nausea degree evaluated by patient's 10-cm visual analogue scale (VAS)
Time Frame
1 Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use central contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Tainan
Country
Taiwan
City
Taipei
ZIP/Postal Code
105
Country
Taiwan

12. IPD Sharing Statement

Links:
URL
https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=150
Description
Link to results on Astellas Clinical Study Results website

Learn more about this trial

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

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