A Study of Ramosetron Plus DX, Dexamethasone, Compared to... | NCT00272285

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

NCT00272285

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Mar 9, 2017Actual

Enrollment

287Actual

Phase

Phase 3

Conditions

Vomiting
Nausea

Interventions

Ramosetron
Granisetron

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Dec 2007Actual

Completion Date

Mar 2008Actual

First Submitted Date

Jan 3, 2006

First Submission Date that Met QC Criteria

Jan 3, 2006

First Posted Date

Jan 5, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2017

Last Update Posted Date

Mar 9, 2017Actual

Name	Class
Astellas Pharma Taiwan, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

287Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Intravenous (IV)	Drug: Ramosetron
2	Active Comparator	Intravenous (IV)	Drug: Granisetron

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ramosetron	Drug	IV, concomitant administration with dexamethasone	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Use central contact	Astellas Pharma Inc	Study Chair

Label	URL
Link to results on Astellas Clinical Study Results website	View source

Condition Browse Module

MeSH Terms

ID	Term
D014839	Vomiting
D009325	Nausea

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C071315	ramosetron
D017829	Granisetron

Ancestor Terms

ID	Term
D053961	Azabicyclo Compounds
D001372	Aza Compounds
D009930	Organic Chemicals
D007191	Indazoles

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Tainan			Taiwan