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

January 19, 2017 updated by: GlaxoSmithKline

Phase II Multicenter, Dose Ranging Study on the Safety and Antiemetic Efficacy of One Day Intraveous Dosing of GW597599 Administered With Ondansetron HCL in a Female Subjects Undergoing Surgical Procedures of High Emetogenic Risk

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

624

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
        • GSK Investigational Site
      • Westmead, New South Wales, Australia, 2145
        • GSK Investigational Site
    • Victoria
      • Carlton, Victoria, Australia, 3186
        • GSK Investigational Site
      • Melbourne, Victoria, Australia, 3004
        • GSK Investigational Site
      • Ringwood East, Victoria, Australia, 3128
        • GSK Investigational Site
    • Western Australia
      • Subiaco, Western Australia, Australia, 6008
        • GSK Investigational Site
  • Belgium
      • Bruxelles, Belgium, 1200
        • GSK Investigational Site
      • Bruxelles, Belgium, 1070
        • GSK Investigational Site
      • Gent, Belgium, 9000
        • GSK Investigational Site
      • Leuven, Belgium, 3000
        • GSK Investigational Site
  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8Z 6R5
        • GSK Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • GSK Investigational Site
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • GSK Investigational Site
      • Oshawa, Ontario, Canada, L1G 2B9
        • GSK Investigational Site
      • Sudbury, Ontario, Canada, P3E 5V9
        • GSK Investigational Site
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada, C1A 8T5
        • GSK Investigational Site
    • Quebec
      • Chandler, Quebec, Canada, G0C 1K0
        • GSK Investigational Site
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4P 0W5
        • GSK Investigational Site
  • Chile
    • Región Metro De Santiago
      • Santiago, Región Metro De Santiago, Chile, 8380456
        • GSK Investigational Site
      • Santiago, Región Metro De Santiago, Chile, 7571831
        • GSK Investigational Site
  • Czech Republic
      • Brno, Czech Republic, 625 00
        • GSK Investigational Site
      • Jihlava, Czech Republic, 586 33
        • GSK Investigational Site
      • Olomouc, Czech Republic, 775 20
        • GSK Investigational Site
      • Ostrava - Poruba, Czech Republic, 708 52
        • GSK Investigational Site
  • Finland
      • Helsinki, Finland, 00029
        • GSK Investigational Site
      • Kuopio, Finland, 70210
        • GSK Investigational Site
  • Netherlands
      • Roosendaal, Netherlands, 4708 AE
        • GSK Investigational Site
      • Rotterdam, Netherlands, 3083 AN
        • GSK Investigational Site
      • Rotterdam, Netherlands, 3011 TD
        • GSK Investigational Site
  • Poland
      • Poznan, Poland, 60-535
        • GSK Investigational Site
      • Warszawa, Poland, 02-781
        • GSK Investigational Site
      • Warszawa, Poland, 02-507
        • GSK Investigational Site
  • South Africa
      • Arcadia, Pretoria, South Africa, 0083
        • GSK Investigational Site
      • Bloemfontein, South Africa, 9301
        • GSK Investigational Site
  • Turkey
      • Istanbul, Turkey, 34303
        • GSK Investigational Site
      • Istanbul, Turkey
        • GSK Investigational Site
  • United Kingdom
    • Essex
      • Chelmsford, Essex, United Kingdom, CM1 7ET
        • GSK Investigational Site
    • Northamptonshire
      • Northampton, Northamptonshire, United Kingdom, NN1 5BD
        • GSK Investigational Site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • GSK Investigational Site
    • California
      • Glendale, California, United States, 91206
        • GSK Investigational Site
      • Laguna Hills, California, United States, 95660
        • GSK Investigational Site
      • Los Angeles, California, United States, 90048
        • GSK Investigational Site
      • Los Angeles, California, United States, 90089
        • GSK Investigational Site
      • Pasadena, California, United States, 91109
        • GSK Investigational Site
    • Florida
      • Boca Raton, Florida, United States, 33067
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • GSK Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • GSK Investigational Site
    • New York
      • Albany, New York, United States, 12208
        • GSK Investigational Site
      • New York, New York, United States, 10021
        • GSK Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • GSK Investigational Site
      • Raleigh, North Carolina, United States, 27609
        • GSK Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, United States, 75390-9135
        • GSK Investigational Site
      • Houston, Texas, United States, 77024
        • GSK Investigational Site
    • Washington
      • Spokane, Washington, United States, 99204
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • known risk factors for PONV.
  • Undergoing gynecological or gallbladder surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The number of subjects who achieve a complete antiemetic response during the first 24 hour evaluation period following the emergence from anesthesia.

Secondary Outcome Measures

Outcome Measure
The number of subjects who achieve a complete antiemetic response during each subsequent 24 hour evaluation period (up to 120 hours) following the emergence from anesthesia.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

January 15, 2008

First Submitted That Met QC Criteria

January 15, 2008

First Posted (Estimate)

January 25, 2008

Study Record Updates

Last Update Posted (Estimate)

January 20, 2017

Last Update Submitted That Met QC Criteria

January 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NKO101287

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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