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Casopitant And ZOFRAN To Prevent Post Operative 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: 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 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

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

Primary outcome: Rates of vomiting and retching after surgery.

Secondary outcome: Rates of nausea after surgery Blood tests to further characterize safety.

Eligibility

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

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.

Locations and Contacts

GSK Clinical Trials Center, Gent 9000, Belgium

GSK Clinical Trials Center, Aalst 9300, Belgium

GSK Clinical Trials Center, Brasschaat 2930, Belgium

GSK Clinical Trials Call Center, Bruxelles 1200, Belgium

GSK Clinical Trials Call Center, Jihlava 586 01, Czech Republic

GSK Clinical Trials Call Center, Olomouc 775 20, Czech Republic

GSK Clinical Trials Call Center, Pardubice 532 03, Czech Republic

GSK Clinical Trials Call Center, Praha 128 51, Czech Republic

GSK Clinical Trials Call Center, Praha 150 08, Czech Republic

GSK Clinical Trials Call Center, Jihlava 586 33, Czech Republic

GSK Clinical Trials Call Center, Brno 625 00, Czech Republic

GSK Clinical Trials Call Center, Neubrandenburg 17036, Germany

GSK Clinical Trials Call Center, Rostock 18059, Germany

GSK Clinical Trials Call Center, Schwerin 19055, Germany

GSK Clinical Trials Call Center, Wismar 23966, Germany

GSK Clinical Trials Call Center, Kiel 24105, Germany

GSK Clinical Trials Call Center, Sha Tin, Hong Kong

GSK Clinical Trials Call Center, Sha Tin, Hong Kong

GSK Clinical Trials Call Center, Pokfulam, Hong Kong

GSK Clinical Trials Call Center, Kwun Tong, Hong Kong

GSK Clinical Trials Call Center, Kowloon, Hong Kong

GSK Clinical Trials Call Center, Szentes 6600, Hungary

GSK Clinical Trials Call Center, Szekesfehervar 8001, Hungary

GSK Clinical Trials Call Center, Seoul 138-736, Korea, Republic of

GSK Clinical Trials Call Center, Lahore 54700, Pakistan

GSK Clinical Trials Call Center, Manila 1004, Philippines

GSK Clinical Trials Call Center, Quezon City 1104, Philippines

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

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

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

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

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

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

GSK Clinical Trials Call Center, Perm 614107, Russian Federation

GSK Clinical Trials Call Center, Moscow 101000, Russian Federation

GSK Clinical Trials Call Center, Krasnodar 350042, Russian Federation

GSK Clinical Trials Call Center, Moscow 111538, Russian Federation

GSK Clinical Trials Call Center, Moscow 117152, Russian Federation

GSK Clinical Trials Call Center, St Petersburg 192242, Russian Federation

GSK Clinical Trials Call Center, Moscow 119992, Russian Federation

GSK Clinical Trials Call Center, Badalona 08916, Spain

GSK Clinical Trials Call Center, Barcelona 08025, Spain

GSK Clinical Trials Call Center, Barcelona 08025, Spain

GSK Clinical Trials Call Center, Pamplona 31008, Spain

GSK Clinical Trials Call Center, Barcelona 08003, Spain

GSK Clinical Trials Call Center, Santiago de Compostela 15706, Spain

GSK Clinical Trials Call Center, La Coruna 15006, Spain

GSK Clinical Trials Call Center, Badalona 08916, Spain

GSK Clinical Trials Call Center, Hospitalet de Llobregat 08907, Spain

GSK Clinical Trials Call Center, Mataro 08304, Spain

GSK Clinical Trials Call Center, Barcelona 08035, Spain

GSK Clinical Trials Call Center, Bangkok 10700, Thailand

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

GSK Clinical Trials Call Center, Fairhope, Alabama 36532, United States

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

GSK Clinical Trials Call Center, Little Rock, Arkansas 72205, United States

GSK Clinical Trials Call Center, Freiburg, Baden-Wurttemberg 79110, Germany

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

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

GSK Clinical Trials Call Center, San Clemente, California 92672, United States

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

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

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

GSK Clinical Trials Call Center, Boca Raton, Florida 33486, United States

GSK Clinical Trials Call Center, Miami, Florida 33173, United States

GSK Clinical Trials Call Center, West Palm Beach, Florida 33409, United States

GSK Clinical Trials Call Center, Pretoria, Gauteng 0083, South Africa

GSK Clinical Trials Call Center, Pretoria, Gauteng 0084, South Africa

GSK Clinical Trials Call Center, Johannesburg, Gauteng 143, South Africa

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

GSK Clinical Trials Call Center, Chicago, Illinois 60637, United States

GSK Clinical Trials Call Center, Kansas City, Kansas 66160, United States

GSK Clinical Trials Call Center, Edgewood, Kentucky 41017, United States

GSK Clinical Trials Call Center, Baltimore, Maryland 21229, United States

GSK Clinical Trials Call Center, Royal Oak, Michigan 48073, United States

GSK Clinical Trials Call Center, Great Neck, New York 11021, United States

GSK Clinical Trials Call Center, Great Neck, New York 11021, United States

GSK Clinical Trials Call Center, Mineola, New York 11501, United States

GSK Clinical Trials Call Center, Winston-Salem, North Carolina 27103, United States

GSK Clinical Trials Call Centre, Halifax, Nova Scotia B3H 3A7, Canada

GSK Clinical Trials Call Center, Oklahoma City, Oklahoma 73104, United States

GSK Clinical Trials Call Centre, Toronto, Ontario M5T 2S8, Canada

GSK Clinical Trials Call Centre, Sherbrooke, Quebec J1H 5N4, Canada

GSK Clinical Trials Call Centre, Ste-Foy, Quebec G1V 4G2, Canada

GSK Clinical Trials Call Center, Ludwigshafen, Rheinland-Pfailz 67063, Germany

GSK Clinical Trials Call Center, Homburg/ Saar, Saarland 66421, Germany

GSK Clinical Trials Call Center, Halle, Sachsen-Anhalt 06120, Germany

GSK Clinical Trials Call Center, Winchester, Virginia 22601, United States

GSK Clinical Trials Call Center, Charlottesville, Virginia 22908, United States

GSK Clinical Trials Call Center, Seattle, Washington 98195, United States

Additional Information

Starting date: April 2006
Last updated: August 10, 2007

Page last updated: June 20, 2008

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