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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Taiwan, Inc.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00272285
First received: January 3, 2006
Last updated: April 24, 2008
Last verified: April 2008
History of Changes

January 3, 2006
April 24, 2008
January 2006
December 2007   (final data collection date for primary outcome measure)
Proportion of patients without vomiting after the start of chemotherapy for 24 hours [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00272285 on ClinicalTrials.gov Archive Site
  • Response rate of vomiting prevention [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • The number of vomiting episodes [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • The nausea degree evaluated by patient's 10-cm visual analogue scale (VAS) [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Study of Ramosetron Plus DX, Dexamethasone, Compared to Granisetron Plus DX for the Prevention of Vomiting and Nausea
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Vomiting
  • Nausea
  • Drug: Ramosetron
    IV, concomitant administration with dexamethasone
  • Drug: Granisetron
    IV, concomitant administration with dexamethasone
  • Experimental: 1
    Intervention: Drug: Ramosetron
  • Active Comparator: 2
    Intervention: Drug: Granisetron
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
287
March 2008
December 2007   (final data collection date for primary outcome measure)

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
Both
20 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00272285
06003/TnIO01
No
Director, Astellas Pharma Inc.
Astellas Pharma Inc
Astellas Pharma Taiwan, Inc.
Study Chair: Use central contact Astellas Pharma Inc
Astellas Pharma Inc
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP