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

This study has been completed.

First Received: January 3, 2006 Last Updated: April 24, 2008 History of Changes

Sponsors and Collaborators:	Astellas Pharma Inc Astellas Pharma Taiwan, Inc.
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00272285

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Dexamethasone Serotonin Dexamethasone acetate Doxiproct plus Granisetron hydrochloride Granisetron Ramosetron YM 060 Dexamethasone Sodium Phosphate

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
1: Experimental	Drug: Ramosetron IV, concomitant administration with dexamethasone
2: Active Comparator	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

Taipei, Taiwan, 105

Tainan, Taiwan

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

Keywords provided by Astellas Pharma Inc:

Serotonin antagonists
Combination drug therapy
Randomized controlled trial
Double-blind method

Study placed in the following topic categories:

Anti-Inflammatory Agents
Dexamethasone
Neurotransmitter Agents
Vomiting
Antineoplastic Agents, Hormonal
Signs and Symptoms, Digestive
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Ramosetron

Antiemetics
Glucocorticoids
Hormones
Serotonin
Signs and Symptoms
Nausea
Granisetron
Peripheral Nervous System Agents
Dexamethasone acetate

Additional relevant MeSH terms:

Dexamethasone
Anti-Inflammatory Agents
Neurotransmitter Agents
Vomiting
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Signs and Symptoms
Serotonin Antagonists

Therapeutic Uses
Nausea
Dexamethasone acetate
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Ramosetron
Glucocorticoids
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Peripheral Nervous System Agents
Granisetron
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 01, 2009