Casopitant (Oral) And ZOFRAN To Prevent Postoperative Nausea And Vomiting In Women

This study has been completed.

First Received: May 12, 2006 Last Updated: May 15, 2009 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00326248

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: GW679769 (casopitant)	Phase III

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 50 mg Oral Dosing With the Neurokinin-1 Receptor Antagonist GW679769 for the Prevention of Postoperative Nausea and Vomiting in Female Subjects at High Risk for Emesis

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Ondansetron hydrochloride Ondansetron Casopitant Casopitant mesylate GW679769

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Rates of vomiting and retching [ Time Frame: after surgery ]

Secondary Outcome Measures:

Rates of nausea. Blood test results. [ Time Frame: after surgery ]

Enrollment:	482
Study Start Date:	March 2006
Study Completion Date:	July 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 and/or motion sickness.
Have not smoked for the last 6 months.
Having certain types of abdominal, breast or shoulder surgeries.

Exclusion criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326248

Show 55 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:	NKT102553
Study First Received:	May 12, 2006
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00326248 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 September 01, 2009