Ramosetron Versus Ondansetron for Radiotherapy Induced Na... | NCT00971399

Studies
Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting

NCT00971399

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Feb 28, 2011Estimated

Enrollment

172Estimated

Phase

Phase 3

Conditions

Radiotherapy Induced Nausea and Vomiting

Interventions

ramosetron
ondansetron

Countries

South Korea

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

ID	Type	Description	Link
0808-011-252

Status Module

Record Verification Date

Feb 2011

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

Sep 2009

Primary Completion Date

Feb 2011Actual

Completion Date

Not provided

First Submitted Date

Sep 2, 2009

First Submission Date that Met QC Criteria

Sep 2, 2009

First Posted Date

Sep 3, 2009Estimated

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

Feb 24, 2011

Last Update Posted Date

Feb 28, 2011Estimated

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 prophylactic effect of ondansetron versus ramosetron on radiotherapy induced nausea and vomiting in the treatment of gastrointestinal cancer.
To verify an improvement of 20% in complete response rate in term of radiotherapy induced nausea and vomiting (from 60% with ondansetron to 80% with ramosetron).

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

172Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RMS	Experimental	ramosetron 0.1mg q.d. SL on D1-5	Drug: ramosetron
ODS	Active Comparator	ondansetron 8mg, b.i.d SL on D1-5	Drug: ondansetron

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ramosetron	Drug	ramosetron 0.1mg q.d. SL on D1-5	RMS
ondansetron

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
complete response of RINV (no vomiting and no rescue medication)		4 weeks after medication

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

AJCC 1-3 staged gastrointestinal cancer patient
patient undergoing radiotherapy as treatment
age 20 yr and higher
ECOG 0-2

Exclusion Criteria:

age < 20
ECOG 3-4
patient experiencing nausea or vomiting prior to accrual
patient under antiemetic medication
patient under steroid medication (topical or inhalant steroid application are exceptional)
patient under opioid medication

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		110-744	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19060294	Background	Kim K, Chie EK, Jang JY, Kim SW, Oh DY, Im SA, Kim TY, Bang YJ, Ha SW. Ramosetron for the prevention of nausea and vomiting during 5-fluorouracil-based chemoradiotherapy for pancreatico-biliary cancer. Jpn J Clin Oncol. 2009 Feb;39(2):111-5. doi: 10.1093/jjco/hyn140. Epub 2008 Dec 5.

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

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds