Palonosetron Versus Ramosetron for the Prevention of Post... | NCT01476280

Studies
Palonosetron Versus Ramosetron for the Prevention of Postoperative Nausea and Vomiting

NCT01476280

Sponsor

Incheon St.Mary's Hospital

Status

Completed

Last Update Posted

Nov 22, 2011Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

Postoperative Nausea and Vomiting

Interventions

palonosetron
Ramosetron

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

Status Module

Record Verification Date

Nov 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

May 2011

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Nov 15, 2011

First Submission Date that Met QC Criteria

Nov 17, 2011

First Posted Date

Nov 22, 2011Estimated

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

Nov 17, 2011

Last Update Posted Date

Nov 22, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Ramosetron and palonosetron are more recently developed 5-hydroxytryptamine type 3 receptor antagonists and this randomized double blind study was designed to compare efficacy of ramosetron and palonosetron to prevent postoperative nausea and vomiting. Investigator hypothesized that palonosetron would have stronger and longer lasting antiemetic effect compared with ramosetron and evaluated the patients for the first 48 hours after surgery.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Palonosetron	Sham Comparator		Drug: palonosetron
Ramosetron	Sham Comparator		Drug: Ramosetron

Interventions

Name	Type	Description	Arm Group Labels	Other Names
palonosetron	Drug	0.075mg immediately before induction of anesthesia	Palonosetron

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of postoperative nausea and vomiting for 48 hours after surgery		for 48 hours after surgery

Secondary Outcomes

Measure	Description	Time Frame
severity of nausea for 48 hours after surgery		for 48 hours after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA Physical Status 1 or 2
Elective gynaecological laparoscopic surgery of ≥ 1h duration

Exclusion Criteria:

Anti-emetics, steroids, or psychoactive medications within 24 h of study initiation
Vomiting or retching in the 24 h preceding surgery
Cancer chemotherapy within 4 weeks or emetogenic radiotherapy within 8 weeks before study entry
Ongoing vomiting from gastrointestinal disease

Accepts Healthy Volunteers

Sex

Female

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

Name	Affiliation	Role
Soo Kyoung Park	Incheon St.Mary's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Incheon St. Mary's hospital		Incheon		403-720	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D020250	Postoperative Nausea and Vomiting

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009325	Nausea

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077924	Palonosetron
C071315	ramosetron

Ancestor Terms

ID	Term
D011812	Quinuclidines
D006572	Heterocyclic Compounds, Bridged-Ring
D006571	Heterocyclic Compounds
D007546	Isoquinolines

Browse Leaves

Not provided

Browse Branches

Not provided