Clinical trial NCT00600990: Study Of An NK-1 Anti-Emetic Medication For The Prevention Of Post-Operative Nausea And Vomiting In Female Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Nausea and Vomiting
Nausea and Vomiting, Postoperative
Keywords: post-operative nausea and vomiting
PONV
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-01-25
Enrollment: 624
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Eligibility criteria: Inclusion Criteria:

* known risk factors for PONV.
* Undergoing gynecological or gallbladder surgery.

Primary outcomes:
measure: The number of subjects who achieve a complete antiemetic response during the first 24 hour evaluation period following the emergence from anesthesia.
Secondary outcomes:
measure: The number of subjects who achieve a complete antiemetic response during each subsequent 24 hour evaluation period (up to 120 hours) following the emergence from anesthesia.
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Glendale
country: United States
facility: GSK Investigational Site
state: California
city: Laguna Hills
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Pasadena
country: United States
facility: GSK Investigational Site
state: California
city: Boca Raton
country: United States
facility: GSK Investigational Site
state: Florida
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Albany
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Durham
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Spokane
country: United States
facility: GSK Investigational Site
state: Washington
city: St Leonards
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Westmead
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Carlton
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Melbourne
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Ringwood East
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Subiaco
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Gent
country: Belgium
facility: GSK Investigational Site
city: Leuven
country: Belgium
facility: GSK Investigational Site
city: Victoria
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Kingston
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Oshawa
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Sudbury
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Charlottetown
country: Canada
facility: GSK Investigational Site
state: Prince Edward Island
city: Chandler
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Regina
country: Canada
facility: GSK Investigational Site
state: Saskatchewan
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Brno
country: Czech Republic
facility: GSK Investigational Site
city: Jihlava
country: Czech Republic
facility: GSK Investigational Site
city: Olomouc
country: Czech Republic
facility: GSK Investigational Site
city: Ostrava - Poruba
country: Czech Republic
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Kuopio
country: Finland
facility: GSK Investigational Site
city: Roosendaal
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Arcadia, Pretoria
country: South Africa
facility: GSK Investigational Site
city: Bloemfontein
country: South Africa
facility: GSK Investigational Site
city: Istanbul
country: Turkey
facility: GSK Investigational Site
city: Istanbul
country: Turkey
facility: GSK Investigational Site
city: Chelmsford
country: United Kingdom
facility: GSK Investigational Site
state: Essex
city: Northampton
country: United Kingdom
facility: GSK Investigational Site
state: Northamptonshire
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: