Study Of An NK-1 Anti-Emetic Medication For The Prevention Of Post-Operative Nausea And Vomiting In Female Patients
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
1 other identifier
interventional
624
12 countries
55
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2004
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 15, 2008
CompletedFirst Posted
Study publicly available on registry
January 25, 2008
CompletedJanuary 20, 2017
January 1, 2017
1.6 years
January 15, 2008
January 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The number of subjects who achieve a complete antiemetic response during the first 24 hour evaluation period following the emergence from anesthesia.
Secondary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- known risk factors for PONV.
- Undergoing gynecological or gallbladder surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (55)
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Glendale, California, 91206, United States
GSK Investigational Site
Laguna Hills, California, 95660, United States
GSK Investigational Site
Los Angeles, California, 90048, United States
GSK Investigational Site
Los Angeles, California, 90089, United States
GSK Investigational Site
Pasadena, California, 91109, United States
GSK Investigational Site
Boca Raton, Florida, 33067, United States
GSK Investigational Site
Chicago, Illinois, 60611, United States
GSK Investigational Site
Omaha, Nebraska, 68131, United States
GSK Investigational Site
Albany, New York, 12208, United States
GSK Investigational Site
New York, New York, 10021, United States
GSK Investigational Site
Durham, North Carolina, 27710, United States
GSK Investigational Site
Raleigh, North Carolina, 27609, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19141, United States
GSK Investigational Site
Dallas, Texas, 75390-9135, United States
GSK Investigational Site
Houston, Texas, 77024, United States
GSK Investigational Site
Spokane, Washington, 99204, United States
GSK Investigational Site
St Leonards, New South Wales, 2065, Australia
GSK Investigational Site
Westmead, New South Wales, 2145, Australia
GSK Investigational Site
Carlton, Victoria, 3186, Australia
GSK Investigational Site
Melbourne, Victoria, 3004, Australia
GSK Investigational Site
Ringwood East, Victoria, 3128, Australia
GSK Investigational Site
Subiaco, Western Australia, 6008, Australia
GSK Investigational Site
Brussels, 1070, Belgium
GSK Investigational Site
Brussels, 1200, Belgium
GSK Investigational Site
Ghent, 9000, Belgium
GSK Investigational Site
Leuven, 3000, Belgium
GSK Investigational Site
Victoria, British Columbia, V8Z 6R5, Canada
GSK Investigational Site
Halifax, Nova Scotia, B3H 2Y9, Canada
GSK Investigational Site
Greater Sudbury, Ontario, P3E 5V9, Canada
GSK Investigational Site
Kingston, Ontario, K7L 2V7, Canada
GSK Investigational Site
Oshawa, Ontario, L1G 2B9, Canada
GSK Investigational Site
Charlottetown, Prince Edward Island, C1A 8T5, Canada
GSK Investigational Site
Chandler, Quebec, G0C 1K0, Canada
GSK Investigational Site
Regina, Saskatchewan, S4P 0W5, Canada
GSK Investigational Site
Santiago, Región Metro de Santiago, 7571831, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 8380456, Chile
GSK Investigational Site
Brno, 625 00, Czechia
GSK Investigational Site
Jihlava, 586 33, Czechia
GSK Investigational Site
Olomouc, 775 20, Czechia
GSK Investigational Site
Ostrava - Poruba, 708 52, Czechia
GSK Investigational Site
Helsinki, 00029, Finland
GSK Investigational Site
Kuopio, 70210, Finland
GSK Investigational Site
Roosendaal, 4708 AE, Netherlands
GSK Investigational Site
Rotterdam, 3011 TD, Netherlands
GSK Investigational Site
Rotterdam, 3083 AN, Netherlands
GSK Investigational Site
Poznan, 60-535, Poland
GSK Investigational Site
Warsaw, 02-507, Poland
GSK Investigational Site
Warsaw, 02-781, Poland
GSK Investigational Site
Arcadia, Pretoria, 0083, South Africa
GSK Investigational Site
Bloemfontein, 9301, South Africa
GSK Investigational Site
Istanbul, 34303, Turkey (Türkiye)
GSK Investigational Site
Istanbul, Turkey (Türkiye)
GSK Investigational Site
Chelmsford, Essex, CM1 7ET, United Kingdom
GSK Investigational Site
Northampton, Northamptonshire, NN1 5BD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2008
First Posted
January 25, 2008
Study Start
December 1, 2004
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
January 20, 2017
Record last verified: 2017-01