Casopitant And ZOFRAN To Prevent Post Operative Nausea And Vomiting In Women

This study has been completed.

First Received: June 2, 2006 Last Updated: October 15, 2008 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00334152

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 Surgery

Drug Information available for: Ondansetron hydrochloride Ondansetron Casopitant

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, 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:	March 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 64 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD, PhD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	NKT102552
Study First Received:	June 2, 2006
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00334152 History of Changes
Health Authority:	United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration

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

Antiemetics
Nausea
Ondansetron
Substance P
Serotonin

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