A Study To Evaluate An NK-1 Antiemetic For The Prevention Of Post Operative Nausea And Vomiting
Phase 2
Completed
- Conditions
- Postoperative Nausea and VomitingNausea and Vomiting, Postoperative
- Registration Number
- NCT00108095
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This study is looking at a range of doses of this NK-1 receptor antagonist drug, for both safety and effectiveness in prevention PONV
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 701
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (1)
GSK Investigational Site
🇪🇸Santiago de Compostela, Spain