Post-Operative Nausea And Vomiting Study In Female Patients

NCT ID: NCT00274690

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

435 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2005-08-31

Brief Summary

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The primary purpose of this study is to determine an effective dose of this NK-1 anti-emetic medication to prevent nausea and vomiting in females after surgery.

Detailed Description

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A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase II Study to Evaluate the Safety and Efficacy of Oral Dosing with GW679769 (50 mg or 150 mg) for Three Consecutive Days When Administered with a Single Intravenous Dose of 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 Post-operative Nausea and Vomiting Who are Undergoing Laparoscopic/Laparotomic 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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GW679769

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Known, specified risk factors for PONV (post operative nausea and vomiting)
* Undergoing gynecologic or gallbladder surgery.

Exclusion Criteria

* pregnant or breastfeeding
* post-menopausal
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

San Francisco, California, United States

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Melbourne, 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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Grand Rapids, Michigan, United States

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Royal Oak, Michigan, United States

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Camden, New Jersey, United States

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Winston-Salem, North Carolina, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Seattle, Washington, United States

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Copenhagen, , Denmark

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Glostrup Municipality, , Denmark

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Viborg, , Denmark

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Lai Chi Kok, , Hong Kong

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Pokfulam, , Hong Kong

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Shamshuipo, Kowloon, , Hong Kong

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Shatin, New Territories, , Hong Kong

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Tuenmen, , Hong Kong

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Budapest, , Hungary

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Budapest, , Hungary

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Szentes, , Hungary

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Kfar Saba, , Israel

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Tel Litwinsky, , Israel

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Gjettum, , Norway

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Oslo, , Norway

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Skien, , Norway

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Manila, , Philippines

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Manila, , Philippines

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Ljubljana, , Slovenia

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Novo Mesto, , Slovenia

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Slovenj Gradec, , Slovenia

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Badalona(Barcelona), , Spain

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Barcelona, , Spain

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Madrid, , Spain

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Pamplona, , Spain

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Bangkok, , Thailand

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Bangkok, , Thailand

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Glasgow, Lanarkshire, United Kingdom

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Glasgow, Lanarkshire, United Kingdom

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Glasgow, Lanarkshire, United Kingdom

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Edinburgh, Midlothian, United Kingdom

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Livingston, West Lothian, United Kingdom

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Hull, , United Kingdom

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Countries

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United States Denmark Hong Kong Hungary Israel Norway Philippines Slovenia Spain Thailand United Kingdom

Other Identifiers

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NKT102245

Identifier Type: -

Identifier Source: org_study_id

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