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

NCT ID: NCT00334152

Last Updated: 2017-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

515 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2006-07-31

Brief Summary

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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

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Conditions

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Nausea and Vomiting, Postoperative Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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casopitant

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Fairhope, Alabama, United States

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Mobile, Alabama, United States

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Montgomery, Alabama, United States

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Little Rock, Arkansas, United States

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Arcadia, California, United States

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Glendale, California, United States

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Laguna Hills, California, United States

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Pasadena, California, United States

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Boca Raton, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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West Palm Beach, Florida, United States

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Chicago, Illinois, United States

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Kansas City, Kansas, United States

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Baltimore, Maryland, United States

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Royal Oak, Michigan, United States

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Mineola, New York, United States

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New Hyde Park, New York, United States

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New York, New York, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Charlottesville, Virginia, United States

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Winchester, Virginia, United States

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Seattle, Washington, United States

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Aalst, , Belgium

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Brasschaat, , Belgium

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Brussels, , Belgium

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Ghent, , Belgium

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Sainte-Foy, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Brno, , Czechia

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Jihlava, , Czechia

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Olomouc, , Czechia

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Pardubice, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Freiburg im Breisgau, Baden-Wurttemberg, Germany

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Marburg, Hesse, Germany

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Neubrandenburg, Mecklenburg-Vorpommern, Germany

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Rostock, Mecklenburg-Vorpommern, Germany

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Schwerin, Mecklenburg-Vorpommern, Germany

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Wismar, Mecklenburg-Vorpommern, Germany

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Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

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Homburg, Saarland, Germany

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Halle, Saxony-Anhalt, Germany

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Kiel, Schleswig-Holstein, Germany

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Kwun Tong, , Hong Kong

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Pokfulam, , Hong Kong

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Shatin, New Territories, , Hong Kong

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Sheung Shui, New Territories, , Hong Kong

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Lahore, , Pakistan

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Manila, , Philippines

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Quezon City, , Philippines

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Perm, , Russia

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Saint Petersburgh, , Russia

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A Coruña, , Spain

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Badalona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Mataró, , Spain

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Pamplona, , Spain

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Santiago de Compostela, , Spain

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Bangkok, , Thailand

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Countries

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United States Belgium Canada Czechia Germany Hong Kong Pakistan Philippines Russia Spain Thailand

Study Documents

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Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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NKT102552

Identifier Type: -

Identifier Source: org_study_id

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