Post-Operative Nausea And Vomiting Study In Female Patients
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
1 other identifier
interventional
435
11 countries
44
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2005
Shorter than P25 for phase_2
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 9, 2006
CompletedFirst Posted
Study publicly available on registry
January 11, 2006
CompletedJanuary 20, 2017
January 1, 2017
6 months
January 9, 2006
January 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
72 Hours
Secondary Outcomes (1)
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.
120 Hours
Interventions
Eligibility Criteria
You may qualify if:
- Known, specified risk factors for PONV (post operative nausea and vomiting)
- Undergoing gynecologic or gallbladder surgery.
You may not qualify if:
- pregnant or breastfeeding
- post-menopausal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (44)
GSK Investigational Site
San Francisco, California, 94115, United States
GSK Investigational Site
Melbourne, Florida, 32901, United States
GSK Investigational Site
West Palm Beach, Florida, 33409, United States
GSK Investigational Site
Chicago, Illinois, 60637, United States
GSK Investigational Site
Grand Rapids, Michigan, 49525, United States
GSK Investigational Site
Royal Oak, Michigan, 48073, United States
GSK Investigational Site
Camden, New Jersey, 08103-1489, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Seattle, Washington, 98195, United States
GSK Investigational Site
Copenhagen, 2100 Ø, Denmark
GSK Investigational Site
Glostrup Municipality, 2600, Denmark
GSK Investigational Site
Viborg, 8800, Denmark
GSK Investigational Site
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
Tuenmen, Hong Kong
GSK Investigational Site
Budapest, 1115, Hungary
GSK Investigational Site
Budapest, 1124, Hungary
GSK Investigational Site
Szentes, 6600, Hungary
GSK Investigational Site
Kfar Saba, 44281, Israel
GSK Investigational Site
Tel Litwinsky, 52621, Israel
GSK Investigational Site
Gjettum, N-1346, Norway
GSK Investigational Site
Oslo, N-0407, Norway
GSK Investigational Site
Skien, N-3710, Norway
GSK Investigational Site
Manila, 1000, Philippines
GSK Investigational Site
Manila, 1003, Philippines
GSK Investigational Site
Ljubljana, SI-1000, Slovenia
GSK Investigational Site
Novo Mesto, 8000, Slovenia
GSK Investigational Site
Slovenj Gradec, 2380, Slovenia
GSK Investigational Site
Badalona(Barcelona), 08916, Spain
GSK Investigational Site
Barcelona, 08036, Spain
GSK Investigational Site
Madrid, 28046, Spain
GSK Investigational Site
Pamplona, 31008, Spain
GSK Investigational Site
Bangkok, 10330, Thailand
GSK Investigational Site
Bangkok, 10700, Thailand
GSK Investigational Site
Glasgow, Lanarkshire, G11 6NT, United Kingdom
GSK Investigational Site
Glasgow, Lanarkshire, G42 9TY, United Kingdom
GSK Investigational Site
Glasgow, Lanarkshire, G51 4TF, United Kingdom
GSK Investigational Site
Edinburgh, Midlothian, EH16 4SA, United Kingdom
GSK Investigational Site
Livingston, West Lothian, EH54 6PP, United Kingdom
GSK Investigational Site
Hull, HU16 5JD, 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 9, 2006
First Posted
January 11, 2006
Study Start
February 1, 2005
Primary Completion
August 1, 2005
Study Completion
August 1, 2005
Last Updated
January 20, 2017
Record last verified: 2017-01