Study Of An NK-1 Anti-Emetic Medication For The Prevention Of Post-Operative Nausea And Vomiting In Female Patients

This study has been completed.

First Received: January 15, 2008 Last Updated: October 15, 2008 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00600990

Purpose

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).

Condition	Intervention	Phase
Postoperative Nausea and Vomiting	Drug: GW597599	Phase II

MedlinePlus related topics: Anesthesia Nausea and Vomiting

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	See Detailed Description

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

The number of subjects who achieve a complete antiemetic response during the first 24 hour evaluation period following the emergence from anesthesia.

Secondary Outcome Measures:

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.

Estimated Enrollment:	100
Study Start Date:	December 2004

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

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

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600990

Show 59 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	NKO101287
Study First Received:	January 15, 2008
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00600990 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

post-operative nausea and vomiting
PONV

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Nausea and Vomiting
Vomiting
Postoperative Complications

Signs and Symptoms, Digestive
Antiemetics
Nausea

Additional relevant MeSH terms:

Signs and Symptoms
Postoperative Nausea and Vomiting
Pathologic Processes
Vomiting

Postoperative Complications
Signs and Symptoms, Digestive
Nausea

ClinicalTrials.gov processed this record on May 06, 2009