search
Back to results

Post-Operative Nausea And Vomiting Study In Female Patients

Primary Purpose

Postoperative Nausea and Vomiting, Nausea and Vomiting, Postoperative

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GW679769
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring Neurokinin-1 Receptor Antagonist, GW679769, Post-operative Nausea, NK-1 Receptor Antagonist, PONV, Post-discharge Nausea and Vomiting, PDNV, Vomiting

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 9, 2006
Last Updated
January 19, 2017
Sponsor
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT00274690
Brief Title
Post-Operative Nausea And Vomiting Study In Female Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting, Nausea and Vomiting, Postoperative
Keywords
Neurokinin-1 Receptor Antagonist, GW679769, Post-operative Nausea, NK-1 Receptor Antagonist, PONV, Post-discharge Nausea and Vomiting, PDNV, Vomiting

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
435 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GW679769
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
GSK Investigational Site
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
GSK Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
GSK Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
GSK Investigational Site
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Facility Name
GSK Investigational Site
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
GSK Investigational Site
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103-1489
Country
United States
Facility Name
GSK Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
GSK Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
GSK Investigational Site
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
GSK Investigational Site
City
Koebenhavn
ZIP/Postal Code
2100 Ø
Country
Denmark
Facility Name
GSK Investigational Site
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
Facility Name
GSK Investigational Site
City
Lai Chi kok
Country
Hong Kong
Facility Name
GSK Investigational Site
City
Pokfulam
Country
Hong Kong
Facility Name
GSK Investigational Site
City
Shamshuipo, Kowloon
Country
Hong Kong
Facility Name
GSK Investigational Site
City
Shatin, New Territories
Country
Hong Kong
Facility Name
GSK Investigational Site
City
Tuen Mun
Country
Hong Kong
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1124
Country
Hungary
Facility Name
GSK Investigational Site
City
Szentes
ZIP/Postal Code
6600
Country
Hungary
Facility Name
GSK Investigational Site
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
GSK Investigational Site
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
GSK Investigational Site
City
Gjettum
ZIP/Postal Code
N-1346
Country
Norway
Facility Name
GSK Investigational Site
City
Oslo
ZIP/Postal Code
N-0407
Country
Norway
Facility Name
GSK Investigational Site
City
Skien
ZIP/Postal Code
N-3710
Country
Norway
Facility Name
GSK Investigational Site
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
GSK Investigational Site
City
Manila
ZIP/Postal Code
1003
Country
Philippines
Facility Name
GSK Investigational Site
City
Ljubljana
ZIP/Postal Code
SI-1000
Country
Slovenia
Facility Name
GSK Investigational Site
City
Novo Mesto
ZIP/Postal Code
8000
Country
Slovenia
Facility Name
GSK Investigational Site
City
Slovenj Gradec
ZIP/Postal Code
2380
Country
Slovenia
Facility Name
GSK Investigational Site
City
Badalona(Barcelona)
ZIP/Postal Code
08916
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
GSK Investigational Site
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
GSK Investigational Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
GSK Investigational Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
GSK Investigational Site
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G42 9TY
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Edinburgh
State/Province
Midlothian
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Livingston
State/Province
West Lothian
ZIP/Postal Code
EH54 6PP
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Hull
ZIP/Postal Code
HU16 5JD
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Post-Operative Nausea And Vomiting Study In Female Patients

We'll reach out to this number within 24 hrs