Casopitant And ZOFRAN To Prevent Post Operative Nausea And Vomiting In Women - Tabular View

Tracking Information

First Received Date ^ICMJE

June 2, 2006

Last Updated Date

May 15, 2009

Start Date ^ICMJE

March 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Rates of vomiting and retching after surgery.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00334152 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Rates of nausea after surgery Blood tests to further characterize safety.

Original Secondary Outcome Measures ^ICMJE

Rates of nausea after surgery
Blood tests to further characterize safety.

Descriptive Information

Brief Title ^ICMJE

Casopitant And ZOFRAN To Prevent Post Operative Nausea And Vomiting In Women

Official Title ^ICMJE

A Phase III Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of the 30 mg Intravenous Formulation of the Neurokinin-1 Receptor Antagonist GW679769 for Prevention of Postoperative Nausea and Vomiting in Female Subjects at High Risk for Emesis

Brief 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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Postoperative Nausea and Vomiting

Intervention ^ICMJE

Drug: casopitant

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

462

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion criteria:

History of PONV (postoperative nausea and vomiting) and/or motion sickness.
Have not smoked for the last 6 months.
Having certain abdominal, breast, thyroid or shoulder surgery.

Exclusion criteria:

Pregnant or breastfeeding.
Have certain pre-existing medical conditions or take certain medications.

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Belgium, Canada, Czech Republic, Germany, Hong Kong, Pakistan, Philippines, Russian Federation, Spain, Thailand

Administrative Information

NCT ID ^ICMJE

NCT00334152

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

NKT102552

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD, PhD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP