NCT00274690

Post-Operative Nausea And Vomiting Study In Female Patients

A Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Group, Phase II Study to Evaluate the Safety and Efficacy of Oral Dosing With GW679769 (50 mg or 150 mg) for Three Consecutive Days When Administered With a Single Intravenous Dose of 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 Post-operative Nausea and Vomiting Who Are Undergoing Laparoscopic/Laparotomic Surgical Procedures Associated With an Increased Emetogenic Risk

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 435 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to determine an effective dose of this NK-1 anti-emetic medication to prevent nausea and vomiting in females after surgery.

Detailed description

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase II Study to Evaluate the Safety and Efficacy of Oral Dosing with GW679769 (50 mg or 150 mg) for Three Consecutive Days When Administered with a Single Intravenous Dose of 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 Post-operative Nausea and Vomiting Who are Undergoing Laparoscopic/Laparotomic Surgical Procedures Associated with an Increased Emetogenic Risk

Conditions

• Postoperative Nausea and Vomiting
• Nausea and Vomiting, Postoperative

Interventions

Type	Name	Description
DRUG	GW679769

Timeline

• Start date: 2005-02-01
• Primary completion: 2005-08-01
• Completion: 2005-08-01
• First posted: 2006-01-11
• Last updated: 2017-01-20

Locations

44 sites across 11 countries: United States, Denmark, Hong Kong, Hungary, Israel, Norway, Philippines, Slovenia, Spain, Thailand, United Kingdom