Post-Operative Nausea And Vomiting Study In Female Patients

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: January 9, 2006
Last updated: April 14, 2015
Last verified: April 2015
The primary purpose of this study is to determine an effective dose of this NK-1 anti-emetic medication to prevent nausea and vomiting in females after surgery.

Condition Intervention Phase
Postoperative Nausea and Vomiting
Nausea and Vomiting, Postoperative
Drug: GW679769
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: See Detailed Description

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The proportion of subjects who achieve a complete response (defined as no vomiting, no retching, no rescue therapy, & no premature discontinuation from the study) during the first 72 hr evaluation period following the emergence from anesthesia. [ Time Frame: 72 Hours ]

Secondary Outcome Measures:
  • The proportion of subjects who achieve a complete response during each subsequent 24-hr eval period (up to 120 hrs) following the emergence from anesthesia. [ Time Frame: 120 Hours ]

Enrollment: 435
Study Start Date: February 2005
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Detailed Description:
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase II Study to Evaluate the Safety and Efficacy of Oral Dosing with GW679769 (50 mg or 150 mg) for Three Consecutive Days When Administered with a Single Intravenous Dose of Ondansetron Hydrochloride for the Prevention of Post-operative Nausea and Vomiting and Post-discharge Nausea and Vomiting in Female Subjects with Known Risk Factors for Post-operative Nausea and Vomiting Who are Undergoing Laparoscopic/Laparotomic Surgical Procedures Associated with an Increased Emetogenic Risk

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Known, specified risk factors for PONV (post operative nausea and vomiting)
  • Undergoing gynecologic or gallbladder surgery.

Exclusion Criteria:

  • pregnant or breastfeeding
  • post-menopausal
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00274690

  Hide Study Locations
United States, California
GSK Investigational Site
San Francisco, California, United States, 94115
United States, Florida
GSK Investigational Site
Melbourne, Florida, United States, 32901
GSK Investigational Site
West Palm Beach, Florida, United States, 33409
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60637
United States, Michigan
GSK Investigational Site
Grand Rapids, Michigan, United States, 49525
GSK Investigational Site
Royal Oak, Michigan, United States, 48073
United States, New Jersey
GSK Investigational Site
Camden, New Jersey, United States, 08103-1489
United States, North Carolina
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75246
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San Antonio, Texas, United States, 78229
United States, Washington
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Seattle, Washington, United States, 98195
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Glostrup, Denmark, 2600
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Koebenhavn, Denmark, 2100 Ø
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Viborg, Denmark, 8800
Hong Kong
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Lai Chi kok, Hong Kong
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Pokfulam, Hong Kong
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Shamshuipo, Kowloon, Hong Kong
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Shatin, New Territories, Hong Kong
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Tuen Mun, Hong Kong
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Budapest, Hungary, 1115
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Budapest, Hungary, 1124
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Szentes, Hungary, 6600
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Kfar Saba, Israel, 44281
GSK Investigational Site
Tel-Hashomer, Israel, 52621
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Gjettum, Norway, N-1346
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Oslo, Norway, N-0407
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Skien, Norway, N-3710
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Manila, Philippines, 1000
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Manila, Philippines, 1003
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Ljubljana, Slovenia, SI-1000
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Novo Mesto, Slovenia, 8000
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Slovenj Gradec, Slovenia, 2380
GSK Investigational Site
Badalona(Barcelona), Spain, 08916
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Barcelona, Spain, 08036
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Madrid, Spain, 28046
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Pamplona, Spain, 31008
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Bangkok, Thailand, 10330
GSK Investigational Site
Bangkok, Thailand, 10700
United Kingdom
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G11 6NT
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G42 9TY
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G51 4TF
GSK Investigational Site
Edinburgh, Midlothian, United Kingdom, EH16 4SA
GSK Investigational Site
Livingston, West Lothian, United Kingdom, EH54 6PP
GSK Investigational Site
Hull, United Kingdom, HU16 5JD
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00274690     History of Changes
Other Study ID Numbers: NKT102245 
Study First Received: January 9, 2006
Last Updated: April 14, 2015

Keywords provided by GlaxoSmithKline:
Neurokinin-1 Receptor Antagonist
Post-operative Nausea
NK-1 Receptor Antagonist
Post-discharge Nausea and Vomiting

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Neurokinin-1 Receptor Antagonists
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on January 19, 2017