NCT00600990

Study Of An NK-1 Anti-Emetic Medication For The Prevention Of Post-Operative Nausea And Vomiting In Female Patients

Phase II Multicenter, Dose Ranging Study on the Safety and Antiemetic Efficacy of One Day Intraveous Dosing of GW597599 Administered With Ondansetron HCL in a Female Subjects Undergoing Surgical Procedures of High Emetogenic Risk

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 624 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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

Conditions

• Postoperative Nausea and Vomiting
• Nausea and Vomiting, Postoperative

Interventions

Type	Name	Description
DRUG	GW597599

Timeline

• Start date: 2004-12-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2008-01-25
• Last updated: 2017-01-20

Locations

55 sites across 12 countries: United States, Australia, Belgium, Canada, Chile, Czechia, Finland, Netherlands, Poland, South Africa, Turkey (Türkiye), United Kingdom