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

This study has been completed.

First Received on June 2, 2006. Last Updated on March 17, 2011 History of Changes

Sponsor:	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 Nausea and Vomiting, Postoperative	Drug: casopitant	Phase III

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 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

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Ondansetron hydrochloride Ondansetron Casopitant Casopitant mesylate

U.S. FDA Resources

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

Intervention Details:

Other Name: casopitant

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:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00334152 History of Changes
Other Study ID Numbers:	NKT102552
Study First Received:	June 2, 2006
Last Updated:	March 17, 2011
Health Authority:	United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

ondansetron hydrochloride
postoperative nausea and vomiting
casopitant mesylate
5HT3

ZOFRAN
NK-1
PONV
antiemetics

Additional relevant MeSH terms:

Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents

Therapeutic Uses
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on February 09, 2012