Casopitant And ZOFRAN To Prevent Post Operative Nausea And Vomiting In Women - Full Text View

Purpose

This study is being conducted to see if adding GW679769 (casopitant) to ZOFRAN will significantly decrease the number of patients who experience nausea and vomiting after surgery.

Condition	Intervention	Phase
Postoperative Nausea and Vomiting	Drug: casopitant	Phase III

MedlinePlus related topics:

Nausea and Vomiting

ChemIDplus related topics:

Serotonin Ondansetron Ondansetron hydrochloride GW679769

U.S. FDA Resources

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

Official Title:	A Phase III Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of the 30 mg Intravenous Formulation of the Neurokinin-1 Receptor Antagonist GW679769 for Prevention of Postoperative Nausea and Vomiting in Female Subjects at High Risk for Emesis

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Rates of vomiting and retching after surgery.

Secondary Outcome Measures:

Rates of nausea after surgery Blood tests to further characterize safety.

Enrollment:	462
Study Start Date:	April 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

History of PONV (postoperative nausea and vomiting) and/or motion sickness.
Have not smoked for the last 6 months.
Having certain abdominal, breast, thyroid or shoulder surgery.

Exclusion criteria:

Pregnant or breastfeeding.
Have certain pre-existing medical conditions or take certain medications.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334152

Show 90 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical trials, MD, PhD	GlaxoSmithKline

More Information

Study ID Numbers:	NKT102552
First Received:	June 2, 2006
Last Updated:	August 10, 2007
ClinicalTrials.gov Identifier:	NCT00334152
Health Authority:	United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

postoperative nausea and vomiting

PONV

antiemetics

NK-1

5HT3

casopitant mesylate

ZOFRAN

ondansetron hydrochloride

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

Serotonin

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:	NCT00334152