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).
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
624
The number of subjects who achieve a complete antiemetic response during the first 24 hour evaluation period following the emergence from anesthesia.
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.
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GSK Investigational Site
Little Rock, Arkansas, United States
GSK Investigational Site
Glendale, California, United States
GSK Investigational Site
Laguna Hills, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Pasadena, California, United States
GSK Investigational Site
Boca Raton, Florida, United States
GSK Investigational Site
Chicago, Illinois, United States
GSK Investigational Site
Omaha, Nebraska, United States
GSK Investigational Site
Albany, New York, United States
...and 45 more locations