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

NCT ID: NCT00326248

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

482 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2006-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Nausea and Vomiting, Postoperative

Keywords

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postoperative nausea and vomiting PONV antiemetics NK-1 5HT3 casopitant mesylate ZOFRAN ondansetron hydrochloride

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

GW679769 (casopitant)

Intervention Type DRUG

Interventions

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GW679769 (casopitant)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Montgomery, Alabama, United States

Site Status

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Sheffield, Alabama, United States

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Phoenix, Arizona, United States

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Los Angeles, California, United States

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Boynton Beach, Florida, United States

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Jacksonville, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Naples, Florida, United States

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Pensacola, Florida, United States

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Anderson, Indiana, United States

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Grand Rapids, Michigan, United States

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Jackson, Mississippi, United States

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Omaha, Nebraska, United States

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New Brunswick, New Jersey, United States

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New Brunswick, New Jersey, United States

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New York, New York, United States

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New York, New York, United States

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The Bronx, New York, United States

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Altoona, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Spokane, Washington, United States

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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Charlottetown, Prince Edward Island, Canada

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Québec, Quebec, Canada

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Regina, Saskatchewan, Canada

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Bordeaux, , France

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Caen, , France

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Caen, , France

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Lyon, , France

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Lyon, , France

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Paris, , France

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Rennes, , France

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Riom, , France

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Strasbourg, , France

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Marburg, Hesse, Germany

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Aachen, North Rhine-Westphalia, Germany

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Koblenz, Rhineland-Palatinate, Germany

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Pokfulam, , Hong Kong

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Shatin, New Territories, , Hong Kong

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Győr, , Hungary

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Miskolc, , Hungary

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Szentes, , Hungary

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Székesfehérvár, , Hungary

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Dublin, , Ireland

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Galway, , Ireland

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Karachi, , Pakistan

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Manila, , Philippines

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Santa Cruz, Manila, , Philippines

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Bangkok, , Thailand

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Glasgow, Lanarkshire, United Kingdom

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Livingston, West Lothian, United Kingdom

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GSK Investigational Site

Liverpool, , United Kingdom

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Countries

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Denmark Poland South Africa South Korea United States Canada France Germany Hong Kong Hungary Ireland Pakistan Philippines Thailand United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 21339433 (View on PubMed)

Study Documents

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Document Type: Individual Participant Data Set

View Document

Document Type: Clinical Study Report

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Document Type: Dataset Specification

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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

Other Identifiers

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NKT102553

Identifier Type: -

Identifier Source: org_study_id