Study Of An NK-1 Anti-Emetic Medication For The Prevention Of Post-Operative Nausea And Vomiting In Female Patients

NCT ID: NCT00600990

Last Updated: 2017-01-20

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

PHASE2

Total Enrollment

624 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2006-07-31

Brief Summary

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The purpose of this study is to determine the effectiveness of this medication in preventing nausea and vomiting in female patients at risk for post-operative nausea and vomiting (PONV).

Detailed Description

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A Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Group, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Oral (25 mg) and Intravenous (3 mg and 18 mg) Formulations of the Neurokinin-1 Receptor Antagonist, GW597599, When Administered with Intravenous Ondansetron Hydrochloride for the Prevention of Post-operative Nausea and Vomiting and Post-discharge Nausea and Vomiting in Female Subjects with Known Risk Factors for PONV Who are Undergoing Surgical Procedures Associated with an Increased Emetogenic Risk

Conditions

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Postoperative Nausea and Vomiting Nausea and Vomiting, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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GW597599

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* known risk factors for PONV.
* Undergoing gynecological or gallbladder surgery.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 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

Little Rock, Arkansas, United States

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Glendale, California, United States

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Laguna Hills, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Pasadena, California, United States

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Boca Raton, Florida, United States

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Chicago, Illinois, United States

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Omaha, Nebraska, United States

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Albany, New York, United States

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New York, New York, United States

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Durham, North Carolina, United States

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Raleigh, North Carolina, United States

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Philadelphia, Pennsylvania, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Spokane, Washington, United States

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St Leonards, New South Wales, Australia

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Westmead, New South Wales, Australia

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Carlton, Victoria, Australia

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Melbourne, Victoria, Australia

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Ringwood East, Victoria, Australia

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Subiaco, Western Australia, Australia

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Brussels, , Belgium

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Brussels, , Belgium

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Ghent, , Belgium

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Leuven, , Belgium

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Victoria, British Columbia, Canada

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Halifax, Nova Scotia, Canada

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Greater Sudbury, Ontario, Canada

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Kingston, Ontario, Canada

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Oshawa, Ontario, Canada

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Charlottetown, Prince Edward Island, Canada

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Chandler, Quebec, Canada

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Regina, Saskatchewan, Canada

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Santiago, Región Metro de Santiago, Chile

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Santiago, Región Metro de Santiago, Chile

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Brno, , Czechia

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Jihlava, , Czechia

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Olomouc, , Czechia

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Ostrava - Poruba, , Czechia

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Helsinki, , Finland

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Kuopio, , Finland

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Roosendaal, , Netherlands

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Rotterdam, , Netherlands

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Rotterdam, , Netherlands

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Poznan, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Arcadia, Pretoria, , South Africa

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Bloemfontein, , South Africa

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Chelmsford, Essex, United Kingdom

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Northampton, Northamptonshire, United Kingdom

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Countries

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United States Australia Belgium Canada Chile Czechia Finland Netherlands Poland South Africa Turkey (Türkiye) United Kingdom

Other Identifiers

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NKO101287

Identifier Type: -

Identifier Source: org_study_id

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