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

March 7, 2017 updated by: Astellas Pharma Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

287

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan, Taiwan
      • Taipei, Taiwan, 105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Response rate of vomiting prevention
Time Frame: 1 Day
1 Day
The number of vomiting episodes
Time Frame: 1 Day
1 Day
The nausea degree evaluated by patient's 10-cm visual analogue scale (VAS)
Time Frame: 1 Day
1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Astellas Pharma Taiwan, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

January 3, 2006

First Submitted That Met QC Criteria

January 3, 2006

First Posted (Estimate)

January 5, 2006

Study Record Updates

Last Update Posted (Actual)

March 9, 2017

Last Update Submitted That Met QC Criteria

March 7, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06003/TnIO01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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