Post-Operative Nausea And Vomiting Study In Female Patients

January 19, 2017 updated by: GlaxoSmithKline

A Multicenter, Randomised, 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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

435

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

  • Denmark
      • Glostrup, Denmark, 2600
        • GSK Investigational Site
      • Koebenhavn, Denmark, 2100 Ø
        • GSK Investigational Site
      • Viborg, Denmark, 8800
        • GSK Investigational Site
  • Hong Kong
      • Lai Chi kok, Hong Kong
        • GSK Investigational Site
      • Pokfulam, Hong Kong
        • GSK Investigational Site
      • Shamshuipo, Kowloon, Hong Kong
        • GSK Investigational Site
      • Shatin, New Territories, Hong Kong
        • GSK Investigational Site
      • Tuen Mun, Hong Kong
        • GSK Investigational Site
  • Hungary
      • Budapest, Hungary, 1115
        • GSK Investigational Site
      • Budapest, Hungary, 1124
        • GSK Investigational Site
      • Szentes, Hungary, 6600
        • GSK Investigational Site
  • Israel
      • Kfar Saba, Israel, 44281
        • GSK Investigational Site
      • Tel-Hashomer, Israel, 52621
        • GSK Investigational Site
  • Norway
      • Gjettum, Norway, N-1346
        • GSK Investigational Site
      • Oslo, Norway, N-0407
        • GSK Investigational Site
      • Skien, Norway, N-3710
        • GSK Investigational Site
  • Philippines
      • Manila, Philippines, 1000
        • GSK Investigational Site
      • Manila, Philippines, 1003
        • GSK Investigational Site
  • Slovenia
      • Ljubljana, Slovenia, SI-1000
        • GSK Investigational Site
      • Novo Mesto, Slovenia, 8000
        • GSK Investigational Site
      • Slovenj Gradec, Slovenia, 2380
        • GSK Investigational Site
  • Spain
      • Badalona(Barcelona), Spain, 08916
        • GSK Investigational Site
      • Barcelona, Spain, 08036
        • GSK Investigational Site
      • Madrid, Spain, 28046
        • GSK Investigational Site
      • Pamplona, Spain, 31008
        • GSK Investigational Site
  • Thailand
      • Bangkok, Thailand, 10330
        • GSK Investigational Site
      • Bangkok, Thailand, 10700
        • GSK Investigational Site
  • United Kingdom
      • Hull, United Kingdom, HU16 5JD
        • GSK Investigational Site
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G51 4TF
        • GSK Investigational Site
      • Glasgow, Lanarkshire, United Kingdom, G11 6NT
        • GSK Investigational Site
      • Glasgow, Lanarkshire, United Kingdom, G42 9TY
        • GSK Investigational Site
    • Midlothian
      • Edinburgh, Midlothian, United Kingdom, EH16 4SA
        • GSK Investigational Site
    • West Lothian
      • Livingston, West Lothian, United Kingdom, EH54 6PP
        • GSK Investigational Site
  • United States
    • California
      • San Francisco, California, United States, 94115
        • GSK Investigational Site
    • Florida
      • Melbourne, Florida, United States, 32901
        • GSK Investigational Site
      • West Palm Beach, Florida, United States, 33409
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • GSK Investigational Site
    • Michigan
      • Grand Rapids, Michigan, United States, 49525
        • GSK Investigational Site
      • Royal Oak, Michigan, United States, 48073
        • GSK Investigational Site
    • New Jersey
      • Camden, New Jersey, United States, 08103-1489
        • GSK Investigational Site
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, United States, 75246
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site
    • Washington
      • Seattle, Washington, United States, 98195
        • 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, specified risk factors for PONV (post operative nausea and vomiting)
  • Undergoing gynecologic or gallbladder surgery.

Exclusion Criteria:

  • pregnant or breastfeeding
  • post-menopausal

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
Time Frame
The proportion of subjects who achieve a complete response (defined as no vomiting, no retching, no rescue therapy, & no premature discontinuation from the study) during the first 72 hr evaluation period following the emergence from anesthesia.
Time Frame: 72 Hours
72 Hours

Secondary Outcome Measures

Outcome Measure
Time Frame
The proportion of subjects who achieve a complete response during each subsequent 24-hr eval period (up to 120 hrs) following the emergence from anesthesia.
Time Frame: 120 Hours
120 Hours

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

February 1, 2005

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

January 9, 2006

First Submitted That Met QC Criteria

January 9, 2006

First Posted (Estimate)

January 11, 2006

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

  • NKT102245

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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