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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
  Purpose

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.


Condition Intervention Phase
Vomiting
Nausea
 Drug: Ramosetron
Drug: Granisetron
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Proportion of patients without vomiting after the start of chemotherapy for 24 hours [ Time Frame: 1 Day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 287
Study Start Date: January 2006
Study Completion Date: March 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Ramosetron
IV, concomitant administration with dexamethasone
Active Comparator: 2 Drug: Granisetron
IV, concomitant administration with dexamethasone

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00272285

Locations
Taiwan
Tainan, Taiwan
Taipei, Taiwan, 105
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Taiwan, Inc.
Investigators
Study Chair: Use central contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Director, Astellas Pharma Inc.
ClinicalTrials.gov Identifier: NCT00272285     History of Changes
Other Study ID Numbers: 06003/TnIO01
Study First Received: January 3, 2006
Last Updated: April 24, 2008
Health Authority: Taiwan: Department of Health

Keywords provided by Astellas Pharma Inc:
Serotonin antagonists
Combination drug therapy
Randomized controlled trial
Double-blind method

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Granisetron
Ramosetron
Dexamethasone 21-phosphate
BB 1101
Serotonin Antagonists
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 21, 2013