A Study To Evaluate An NK-1 Antiemetic For The Prevention Of Post Operative Nausea And Vomiting
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This study is looking at a range of doses of this NK-1 receptor antagonist drug, for both safety and effectiveness in prevention PONV
Condition or disease
Postoperative Nausea and VomitingNausea and Vomiting, Postoperative
Drug: intravenous ondansetron
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
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, GW679769, 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 Start Date
Primary Completion Date
Study Completion Date
Resource links provided by the National Library of Medicine
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
Secondary Outcome Measures
Number of subjects who achieve a complete response during each subsequent 24 hour evaluation period (up to 120 hours)following the emergence from anesthesia
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Ages Eligible for Study:
18 Years to 55 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Females age 18-55
Laparoscopic/laparotomic gynecological procedure of laparoscopic gallbladder removal