Casopitant (Oral) And ZOFRAN To Prevent Postoperative Nausea And Vomiting In Women

Nausea and Vomiting, Postoperative Clinical Trial

Official title:

A Phase III, Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of 50mg Oral Dosing With the Neurokinin-1 Receptor Antagonist GW679769 for the Prevention of Postoperative Nausea and Vomiting in Female Subjects at High Risk for Emesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00326248
• Other study ID #: NKT102553
• Status: Completed
• Phase: Phase 3
• First received: May 12, 2006
• Last updated: October 24, 2016
• Start date: March 2006
• Est. completion date: July 2006

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

This study is being conducted to see if adding GW679769 (casopitant) to ZOFRAN will significantly decrease the number of patients who experience nausea and vomiting after surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 482
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• History of PONV and/or motion sickness.

• Have not smoked for the last 6 months.

• Having certain types of abdominal, breast or shoulder surgeries.

Exclusion criteria:

• Pregnant or breastfeeding.

• Taking certain medications.

• Have certain pre-existing medical conditions.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Nausea and Vomiting, Postoperative
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• GW679769 (casopitant)

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Charlottetown	Prince Edward Island
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	Quebec
Canada	GSK Investigational Site	Regina	Saskatchewan
Canada	GSK Investigational Site	Vancouver	British Columbia
France	GSK Investigational Site	Bordeaux
France	GSK Investigational Site	Caen Cedex
France	GSK Investigational Site	Caen Cedex
France	GSK Investigational Site	Lyon
France	GSK Investigational Site	Lyon Cedex 02
France	GSK Investigational Site	Paris Cedex 20
France	GSK Investigational Site	Rennes
France	GSK Investigational Site	Riom
France	GSK Investigational Site	Strasbourg
Germany	GSK Investigational Site	Aachen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Koblenz	Rheinland-Pfalz
Germany	GSK Investigational Site	Marburg	Hessen
Hong Kong	GSK Investigational Site	Pokfulam
Hong Kong	GSK Investigational Site	Shatin, New Territories
Hungary	GSK Investigational Site	Gyor
Hungary	GSK Investigational Site	Miskolc
Hungary	GSK Investigational Site	Székesfehérvár
Hungary	GSK Investigational Site	Szentes
Ireland	GSK Investigational Site	Dublin
Ireland	GSK Investigational Site	Galway
Pakistan	GSK Investigational Site	Karachi
Philippines	GSK Investigational Site	Manila
Philippines	GSK Investigational Site	Sta. Cruz, Manila
Thailand	GSK Investigational Site	Bangkok
United Kingdom	GSK Investigational Site	Glasgow	Lanarkshire
United Kingdom	GSK Investigational Site	Liverpool
United Kingdom	GSK Investigational Site	Livingston	West Lothian
United States	GSK Investigational Site	Altoona	Pennsylvania
United States	GSK Investigational Site	Anderson	Indiana
United States	GSK Investigational Site	Boynton Beach	Florida
United States	GSK Investigational Site	Bronx	New York
United States	GSK Investigational Site	Grand Rapids	Michigan
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Jackson	Mississippi
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Melbourne	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Montgomery	Alabama
United States	GSK Investigational Site	Naples	Florida
United States	GSK Investigational Site	New Brunswick	New Jersey
United States	GSK Investigational Site	New Brunswick	New Jersey
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Pensacola	Florida
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	Sheffield	Alabama
United States	GSK Investigational Site	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Hong Kong,  Hungary,  Ireland,  Pakistan,  Philippines,  Thailand,  United Kingdom, 

References & Publications (1)

Altorjay A, Melson T, Chinachoit T, Kett A, Aqua K, Levin J, Blackburn LM, Lane S, Pergolizzi JV Jr. Casopitant and ondansetron for postoperative nausea and vomiting prevention in women at high risk for emesis: a phase 3 study. Arch Surg. 2011 Feb;146(2):201-6. doi: 10.1001/archsurg.2010.327. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of vomiting and retching		after surgery
Secondary	Rates of nausea. Blood test results.		after surgery

External Links

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