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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00326248

First received: May 12, 2006

Last updated: May 31, 2012

Last verified: March 2011

History of Changes

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 Nausea and Vomiting, Postoperative	Drug: GW679769 (casopitant)	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
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

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Show 54 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Altorjay A, Melson T, Chinachoit T, Kett A, Aqua K, Levin J, Blackburn LM, Lane S, Pergolizzi JV Jr. Casopitant and ondansetron for postoperative nausea and vomiting prevention in women at high risk for emesis: a phase 3 study. Arch Surg. 2011 Feb;146(2):201-6. doi: 10.1001/archsurg.2010.327.


Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00326248 History of Changes
Other Study ID Numbers:	NKT102553
Study First Received:	May 12, 2006
Last Updated:	May 31, 2012
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

Additional relevant MeSH terms:


Nausea Vomiting Postoperative Nausea and Vomiting Signs and Symptoms, Digestive Signs and Symptoms Postoperative Complications Pathologic Processes Casopitant	Neurokinin-1 Receptor Antagonists Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 27, 2016

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