This study is looking at a range of doses of this NK-1 receptor antagonist drug, for both safety and effectiveness in prevention PONV
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of the Oral Neurokinin-1 Receptor Antagonist, GW67969, When Administered With Intravenous Ondansetron Hydrochloride for the Prevention of Post-Operative Nausea and Vomiting (PONV) and Post-Discharge Nausea and Vomiting (PDNV) 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
TREATMENT
Masking
DOUBLE
Enrollment
701
Number of subjects who achieve a complete response (defined as no vomiting, no retching, no rescue therapy, and no premature discontinuation from the study) during the first 24 hour evaluation period following emergence from anesthesia
Number of subjects who achieve a complete response during each subsequent 24 hour evaluation period (up to 120 hours)following the emergence from anesthesia
The extent of nausea experienced by subjects.
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GSK Investigational Site
Montgomery, Alabama, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Arcadia, California, United States
GSK Investigational Site
Duarte, California, United States
GSK Investigational Site
Glendale, California, United States
GSK Investigational Site
Laguna Hills, California, United States
GSK Investigational Site
Loma Linda, California, United States
GSK Investigational Site
Pasadena, California, United States
GSK Investigational Site
San Diego, California, United States
GSK Investigational Site
Stanford, California, United States
...and 48 more locations