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

Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postoperative Nausea and Vomiting

Intervention: GW679769 (casopitant) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical trials, MD, PhD, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

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

Study design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Rates of vomiting and retching

Secondary outcome: Rates of nausea. Blood test results.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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.

Locations and Contacts

GSK Clinical Trials Call Centre, Quebec G1L 3L5, Canada

GSK Clinical Trials Call Centre, Lyon 69288, France

GSK Clinical Trials Call Centre, Lyon 69008, France

GSK Clinical Trials Call Centre, Rennes 35000, France

GSK Clinical Trials Call Centre, Bordeaux 33000, France

GSK Clinical Trials Call Centre, Caen 14050, France

GSK Clinical Trials Call Centre, Paris 75015, France

GSK Clinical Trials Call Centre, Strasbourg 67098, France

GSK Clinical Trials Call Centre, Paris 75970, France

GSK Clinical Trials Call Centre, Riom 63204, France

GSK Clinical Trials Call Centre, Lai Chi Kok, Hong Kong

GSK Clinical Trials Call Centre, Tuen Mun, Hong Kong

GSK Clinical Trials Call Centre, Pokfulam, Hong Kong

GSK Clinical Trials Call Centre, Shatin, Hong Kong

GSK Clinical Trials Call Centre, Gyor 9023, Hungary

GSK Clinical Trials Call Centre, Szentes 6600, Hungary

GSK Clinical Trials Call Centre, Szekesfehervar 8001, Hungary

GSK Clinical Trials Call Centre, Miskolc 3529, Hungary

GSK Clinical Trials Call Centre, Budapest 1124, Hungary

GSK Clinical Trials Call Centre, Galway, Ireland

GSK Clinical Trials Call Centre, Dublin, Ireland

GSK Clinical Trials Call Centre, Seoul 110-744, Korea, Republic of

GSK Clinical Trials Call Centre, Karachi 75510, Pakistan

GSK Clinical Trials Call Centre, Karachi 74800, Pakistan

GSK Clinical Trials Call Centre, Manilla 1003, Philippines

GSK Clinical Trials Call Centre, Manilla, Philippines

GSK Clinical Trials Call Centre, Poznan 60-355, Poland

GSK Clinical Trials Call Centre, Poznan 60-533, Poland

GSK Clinical Trials Call Centre, Poznan 61-848, Poland

GSK Clinical Trials Call Centre, Warszawa 02-781, Poland

GSK Clinical Trials Call Centre, Warszawa 02-097, Poland

GSK Clinical Trials Call Centre, Warszawa 02-507, Poland

GSK Clinical Trials Call Centre, Pretoria 157, South Africa

GSK Clinical Trials Call Centre, Pretoria, South Africa

GSK Clinical Trials Call Centre, Orangegrove, Linksfield West 1600, South Africa

GSK Clinical Trials Call Centre, Bangkok 10700, Thailand

GSK Clinical Trials Call Centre, Cardiff CF14 4XN, United Kingdom

GSK Clinical Trials Call Centre, Wigan WN6 9EP, United Kingdom

GSK Clinical Trials Call Centre, Liverpool L8 7SS, United Kingdom

GSK Clinical Trials Call Centre, Salford M6 8HD, United Kingdom

GSK Clinical Trials Call Centre, Glasgow G12 0YN, United Kingdom

GSK Clinical Trials Call Centre, Glasgow G42 9TY, United Kingdom

GSK Clinical Trials Call Centre, Newcastle NE1 4PL, United Kingdom

GSK Clinical Trials Call Centre, Middlesborough TS4 3BW, United Kingdom

GSK Clinical Trials Call Center, Montgomery, Alabama 36106, United States

GSK Clinical Trials Call Center, Sheffield, Alabama 35660, United States

GSK Clinical Trials Call Center, Mobile, Alabama 36608, United States

GSK Clinical Trials Call Center, Mobile, Alabama 36608, United States

GSK Clinical Trials Call Center, Birmingham, Alabama 35209, United States

GSK Clinical Trials Call Centre, Edmonton, Alberta T5H 3V9, Canada

GSK Clinical Trials Call Center, Phoenix, Arizona 85054, United States

GSK Clinical Trials Call Center, Phoenix, Arizona 85030, United States

GSK Clinical Trials Call Center, Arcadia, California 91007, United States

GSK Clinical Trials Call Center, Los Angeles, California 90033, United States

GSK Clinical Trials Call Center, Loma Linda, California 92354, United States

GSK Clinical Trials Call Center, Pasedena, California 91109, United States

GSK Clinical Trials Call Center, Glendale, California 91206, United States

GSK Clinical Trials Call Centre, Caen, Cedex 05 14033, France

GSK Clinical Trials Call Center, Miami, Florida 33136, United States

GSK Clinical Trials Call Center, Jacksonville, Florida 32216, United States

GSK Clinical Trials Call Center, Boyton Beach, Florida 33437, United States

GSK Clinical Trials Call Center, Naples, Florida 34108, United States

GSK Clinical Trials Call Center, Pensacola, Florida 32503, United States

GSK Clinical Trials Call Center, Melbourne, Florida 32901, United States

GSK Clinical Trials Call Center, Atlanta, Georgia 30328, United States

GSK Clinical Trials Call Centre, Marburg, Hessen 35043, Germany

GSK Clinical Trials Call Center, Anderson, Indiana 46011, United States

GSK Clinical Trials Call Center, Grand Rapids, Minnesota 49503, United States

GSK Clinical Trials Call Center, Jackson, Mississippi 39202, United States

GSK Clinical Trials Call Center, Omaha, Nebraska 68131, United States

GSK Clinical Trials Call Center, New Brunswick, New Jersey 08901, United States

GSK Clinical Trials Call Center, New York, New York 10025, United States

GSK Clinical Trials Call Center, Binghamton, New York 13903, United States

GSK Clinical Trials Call Center, Bronx, New York 10467, United States

GSK Clinical Trials Call Center, New York, New York 10016, United States

GSK Clinical Trials Call Centre, Aachen, Nordrhein-Westfalen 52074, Germany

GSK Clinical Trials Call Center, Winston-Salem, North Carolina 49503, United States

GSK Clinical Trials Call Centre, Kingston, Ontario K7L 2V7, Canada

GSK Clinical Trials Call Center, Pittsburgh, Pennsylvania 15213, United States

GSK Clinical Trials Call Center, Philadelphia, Pennsylvania 19102, United States

GSK Clinical Trials Call Center, Hershey, Pennsylvania 17033, United States

GSK Clinical Trials Call Center, Pittsburgh, Pennsylvania 15232, United States

GSK Clinical Trials Call Center, Altoona, Pennsylvania 16602, United States

GSK Clinical Trials Call Centre, Charlottetown, Prince Edward Island C1A 8T5, Canada

GSK Clinical Trials Call Centre, Koblenz, Rheinland-Pfailz 56073, Germany

GSK Clinical Trials Call Centre, Regina, Saskatchewan S4P 0W5, Canada

GSK Clinical Trials Call Center, Houston, Texas 77030, United States

GSK Clinical Trials Call Center, San Antonio, Texas 78240, United States

GSK Clinical Trials Call Center, Spokane, Washington 99204, United States

GSK Clinical Trials Call Centre, Livingston, West Lothian EH54 6PP, United Kingdom

Additional Information

Starting date: March 2006
Ending date: July 2006
Last updated: November 30, 2007

Page last updated: June 20, 2008

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