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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Nausea and Vomiting, Postoperative	Drug: GW679769 (casopitant)	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	482 participants
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
Study Start Date :	March 2006
Actual Primary Completion Date :	July 2006
Actual Study Completion Date :	July 2006

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Arm 1	Drug: GW679769 (casopitant)

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 58 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. 

Study Data/Documents: Individual Participant Data Set 

Identifier: NKT102553
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: NKT102553
For additional information about this study please refer to the GSK Clinical Study Register

Annotated Case Report Form 

Identifier: NKT102553
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form 

Identifier: NKT102553
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: NKT102553
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: NKT102553
For additional information about this study please refer to the GSK Clinical Study Register

Dataset Specification 

Identifier: NKT102553
For additional information about this study please refer to the GSK Clinical Study Register

Publications:

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
First Posted:	May 16, 2006
Last Update Posted:	October 26, 2016
Last Verified:	October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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