Post-Operative Nausea And Vomiting Study In Female Patients

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Postoperative Nausea and Vomiting; Nausea and Vomiting, Postoperative

Treatments: Drug: GW679769

Study type: Interventional

Funder types: Industry

Identifiers

NCT00274690

NKT102245

Details and patient eligibility

About

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.

Full 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

Enrollment: 435 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Known, specified risk factors for PONV (post operative nausea and vomiting)
• Undergoing gynecologic or gallbladder surgery.

Exclusion criteria

• pregnant or breastfeeding
• post-menopausal

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind