Clinical trial NCT00274690: Post-Operative Nausea And Vomiting Study In Female Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Nausea and Vomiting
Nausea and Vomiting, Postoperative
Keywords: Neurokinin-1 Receptor Antagonist
GW679769
Post-operative Nausea
NK-1 Receptor Antagonist
PONV
Post-discharge Nausea and Vomiting
PDNV
Vomiting
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-01-11
Enrollment: 435
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 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

Eligibility criteria: 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

Primary outcomes:
measure: The proportion of subjects who achieve a complete response (defined as no vomiting, no retching, no rescue therapy, & no premature discontinuation from the study) during the first 72 hr evaluation period following the emergence from anesthesia.
timeFrame: 72 Hours
Secondary outcomes:
measure: The proportion of subjects who achieve a complete response during each subsequent 24-hr eval period (up to 120 hrs) following the emergence from anesthesia.
timeFrame: 120 Hours
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: GSK Investigational Site
state: California
city: Melbourne
country: United States
facility: GSK Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Grand Rapids
country: United States
facility: GSK Investigational Site
state: Michigan
city: Royal Oak
country: United States
facility: GSK Investigational Site
state: Michigan
city: Camden
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Seattle
country: United States
facility: GSK Investigational Site
state: Washington
city: Glostrup
country: Denmark
facility: GSK Investigational Site
city: Koebenhavn
country: Denmark
facility: GSK Investigational Site
city: Viborg
country: Denmark
facility: GSK Investigational Site
city: Lai Chi kok
country: Hong Kong
facility: GSK Investigational Site
city: Pokfulam
country: Hong Kong
facility: GSK Investigational Site
city: Shamshuipo, Kowloon
country: Hong Kong
facility: GSK Investigational Site
city: Shatin, New Territories
country: Hong Kong
facility: GSK Investigational Site
city: Tuen Mun
country: Hong Kong
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Szentes
country: Hungary
facility: GSK Investigational Site
city: Kfar Saba
country: Israel
facility: GSK Investigational Site
city: Tel-Hashomer
country: Israel
facility: GSK Investigational Site
city: Gjettum
country: Norway
facility: GSK Investigational Site
city: Oslo
country: Norway
facility: GSK Investigational Site
city: Skien
country: Norway
facility: GSK Investigational Site
city: Manila
country: Philippines
facility: GSK Investigational Site
city: Manila
country: Philippines
facility: GSK Investigational Site
city: Ljubljana
country: Slovenia
facility: GSK Investigational Site
city: Novo Mesto
country: Slovenia
facility: GSK Investigational Site
city: Slovenj Gradec
country: Slovenia
facility: GSK Investigational Site
city: Badalona(Barcelona)
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Pamplona
country: Spain
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
state: Lanarkshire
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
state: Lanarkshire
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
state: Lanarkshire
city: Edinburgh
country: United Kingdom
facility: GSK Investigational Site
state: Midlothian
city: Livingston
country: United Kingdom
facility: GSK Investigational Site
state: West Lothian
city: Hull
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: