Post-Operative Nausea And Vomiting Study In Female Patients - Full Text View

Purpose

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.

Condition	Intervention	Phase
Postoperative Nausea and Vomiting	Drug: GW679769	Phase II

MedlinePlus related topics:

Anesthesia Nausea and Vomiting

ChemIDplus related topics:

Ondansetron Ondansetron hydrochloride GW679769

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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. [ Time Frame: 72 Hours ]

Secondary Outcome Measures:

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. [ Time Frame: 120 Hours ]

Enrollment:	441
Study Start Date:	January 2005

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274690

Show 48 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Study ID Numbers:	NKT102245
First Received:	January 9, 2006
Last Updated:	July 26, 2007
ClinicalTrials.gov Identifier:	NCT00274690
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

GW679769

Neurokinin-1 Receptor Antagonist

NK-1 Receptor Antagonist

Post-operative Nausea

Vomiting

PONV

Post-discharge Nausea and Vomiting

PDNV

Study placed in the following topic categories:

Signs and Symptoms

Postoperative Nausea and Vomiting

Vomiting

Postoperative Complications

Signs and Symptoms, Digestive

Nausea

Ondansetron

Substance P

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00274690