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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00326248

First Posted: May 16, 2006

Last Update Posted: October 26, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

GlaxoSmithKline

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Prevention
Official Title:	A Phase III, Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of 50mg 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
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	Drug: GW679769 (casopitant)

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00326248

Show 58 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Additional Information:

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