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

Primary Purpose

Postoperative Nausea and Vomiting, Nausea and Vomiting, Postoperative

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GW597599
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 post-operative nausea and vomiting, PONV

Eligibility Criteria

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

Inclusion Criteria:

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

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
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  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
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  • GSK Investigational Site
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  • 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 number of subjects who achieve a complete antiemetic response during the first 24 hour evaluation period following the emergence from anesthesia.

Secondary Outcome Measures

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.

Full Information

First Posted
January 15, 2008
Last Updated
January 19, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00600990
Brief Title
Study Of An NK-1 Anti-Emetic Medication For The Prevention Of Post-Operative Nausea And Vomiting In Female Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (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 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
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

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
post-operative nausea and vomiting, PONV

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GW597599
Primary Outcome Measure Information:
Title
The number of subjects who achieve a complete antiemetic response during the first 24 hour evaluation period following the emergence from anesthesia.
Secondary Outcome Measure Information:
Title
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.

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

12. IPD Sharing Statement

Learn more about this trial

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

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