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Casopitant And ZOFRAN To Prevent Post Operative Nausea And Vomiting In Women
This study has been completed.
First Received: June 2, 2006   Last Updated: May 15, 2009   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00334152
  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
Postoperative Nausea and Vomiting
 Drug: casopitant
 Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting Surgery
Drug Information available for: Ondansetron hydrochloride Ondansetron Casopitant
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Rates of vomiting and retching after surgery.

Secondary Outcome Measures:
  • Rates of nausea after surgery Blood tests to further characterize safety.

Enrollment: 462
Study Start Date: March 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00334152

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Montgomery, Alabama, United States, 36106
GSK Investigational Site
Fairhope, Alabama, United States, 36532
GSK Investigational Site
Mobile, Alabama, United States, 36608
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
GSK Investigational Site
Arcadia, California, United States, 91007
GSK Investigational Site
Laguna Hills, California, United States, 92653
GSK Investigational Site
Pasadena, California, United States, 91105
GSK Investigational Site
Glendale, California, United States, 91206
United States, Florida
GSK Investigational Site
West Palm Beach, Florida, United States, 33409
GSK Investigational Site
Melbourne, Florida, United States, 32901
GSK Investigational Site
Boca Raton, Florida, United States, 33067
GSK Investigational Site
Miami, Florida, United States, 33143
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60637
United States, Kansas
GSK Investigational Site
Kansas City, Kansas, United States, 66160
United States, Kentucky
GSK Investigational Site
Edgewood, Kentucky, United States, 41017
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21229-5299
United States, Michigan
GSK Investigational Site
Royal Oak, Michigan, United States, 48073
United States, New York
GSK Investigational Site
New York, New York, United States, 10038
GSK Investigational Site
New Hyde Park, New York, United States, 11040
GSK Investigational Site
Mineola, New York, United States, 11501
United States, North Carolina
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
United States, Virginia
GSK Investigational Site
Winchester, Virginia, United States, 22601
GSK Investigational Site
Charlottesville, Virginia, United States, 22908
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98195
Belgium
GSK Investigational Site
Bruxelles, Belgium, 1200
GSK Investigational Site
Aalst, Belgium, 9300
GSK Investigational Site
Braasschaat, Belgium, 2930
GSK Investigational Site
Gent, Belgium, 9000
Canada, Ontario
GSK Investigational Site
Toronto, Ontario, Canada, M5G 1X5
GSK Investigational Site
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
GSK Investigational Site
Sainte-Foy, Quebec, Canada, G1V 4G2
Czech Republic
GSK Investigational Site
Praha 5, Czech Republic, 150 08
GSK Investigational Site
Olomouc, Czech Republic, 775 20
GSK Investigational Site
Pardubice, Czech Republic, 532 03
GSK Investigational Site
Jihlava, Czech Republic, 586 01
GSK Investigational Site
Praha 2, Czech Republic, 128 51
GSK Investigational Site
Brno, Czech Republic, 625 00
Germany, Baden-Wuerttemberg
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79110
Germany, Mecklenburg-Vorpommern
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18059
GSK Investigational Site
Wismar, Mecklenburg-Vorpommern, Germany, 23966
Germany, Rheinland-Pfalz
GSK Investigational Site
Ludwigshafen, Rheinland-Pfalz, Germany, 67063
Germany, Saarland
GSK Investigational Site
Homburg, Saarland, Germany, 66421
Germany, Sachsen-Anhalt
GSK Investigational Site
Halle, Sachsen-Anhalt, Germany, 06120
Germany, Schleswig-Holstein
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24105
Hong Kong
GSK Investigational Site
Shatin, New Territories, Hong Kong
GSK Investigational Site
Kwun Tong, Hong Kong
Pakistan
GSK Investigational Site
Lahore, Pakistan
Philippines
GSK Investigational Site
Quezon, City, Philippines, 1104
GSK Investigational Site
Manila, Philippines, 1000
Russian Federation
GSK Investigational Site
Perm, Russian Federation, 614107
GSK Investigational Site
Moscow, Russian Federation, 111538
GSK Investigational Site
Moscow, Russian Federation, 101000
GSK Investigational Site
Moscow, Russian Federation, 117152
GSK Investigational Site
St. Petersburgh, Russian Federation, 192242
Spain
GSK Investigational Site
Badalona, Spain, 08916
GSK Investigational Site
Pamplona, Spain, 31008
GSK Investigational Site
Santiago de Compostela, Spain, 15706
GSK Investigational Site
Barcelona, Spain, 08025
GSK Investigational Site
Barcelona, Spain, 08003
GSK Investigational Site
La Coruña, Spain, 15006
GSK Investigational Site
Mataro, Spain, 08034
GSK Investigational Site
Barcelona, Spain, 08035
Thailand
GSK Investigational Site
Bangkok, Thailand
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD, PhD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: NKT102552
Study First Received: June 2, 2006
Last Updated: May 15, 2009
ClinicalTrials.gov Identifier: NCT00334152     History of Changes
Health Authority: United States: Food and Drug Administration;   United Kingdom: Medicines and Healthcare Products Regulatory Agency;   United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
postoperative nausea and vomiting
PONV
antiemetics
NK-1
 5HT3
casopitant mesylate
ZOFRAN
ondansetron hydrochloride

Additional relevant MeSH terms:
Signs and Symptoms
Postoperative Nausea and Vomiting
Pathologic Processes
Vomiting
 Postoperative Complications
Signs and Symptoms, Digestive
Nausea

ClinicalTrials.gov processed this record on November 27, 2009



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