A Study To Evaluate An NK-1 Antiemetic For The Prevention Of Post Operative Nausea And Vomiting

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

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

Treatments: Drug: intravenous ondansetron

Study type: Interventional

Funder types: Industry

Identifiers

NCT00108095

NKT102260

Details and patient eligibility

About

This study is looking at a range of doses of this NK-1 receptor antagonist drug, for both safety and effectiveness in prevention PONV

Full 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

Enrollment: 701 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females age 18-55
• Laparoscopic/laparotomic gynecological procedure of laparoscopic gallbladder removal

Exclusion criteria

• Pregnant or breastfeeding
• Post-menopausal
• Not undergoing general anesthesia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind