Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Post-Operative Nausea And Vomiting Study In Female Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00274690
First received: January 9, 2006
Last updated: May 31, 2012
Last verified: November 2011
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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: 441
Study Start Date: February 2005
Intervention Details:
    Drug: GW679769
    Other Name: GW679769
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00274690

  Hide Study Locations
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
GSK Investigational Site
San Antonio, Texas, United States, 78229
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98195
Denmark
GSK Investigational Site
Glostrup, Denmark, 2600
GSK Investigational Site
Koebenhavn, Denmark, 2100 Ø
GSK Investigational Site
Viborg, Denmark, 8800
Hong Kong
GSK Investigational Site
Lai Chi kok, Hong Kong
GSK Investigational Site
Pokfulam, Hong Kong
GSK Investigational Site
Shamshuipo, Kowloon, Hong Kong
GSK Investigational Site
Shatin, New Territories, Hong Kong
GSK Investigational Site
Tuen Mun, Hong Kong
Hungary
GSK Investigational Site
Budapest, Hungary, 1124
GSK Investigational Site
Budapest, Hungary, 1115
GSK Investigational Site
Szentes, Hungary, 6600
Israel
GSK Investigational Site
Kfar Saba, Israel, 44281
GSK Investigational Site
Tel-Hashomer, Israel, 52621
Norway
GSK Investigational Site
Gjettum, Norway, N-1346
GSK Investigational Site
Oslo, Norway, N-0407
GSK Investigational Site
Skien, Norway, N-3710
Philippines
GSK Investigational Site
Manila, Philippines, 1003
GSK Investigational Site
Manila, Philippines, 1000
Slovenia
GSK Investigational Site
Ljubljana, Slovenia, SI-1000
GSK Investigational Site
Novo Mesto, Slovenia, 8000
GSK Investigational Site
Slovenj Gradec, Slovenia, 2380
Spain
GSK Investigational Site
Badalona(Barcelona), Spain, 08916
GSK Investigational Site
Barcelona, Spain, 08036
GSK Investigational Site
Madrid, Spain, 28046
GSK Investigational Site
Pamplona, Spain, 31008
Thailand
GSK Investigational Site
Bangkok, Thailand, 10700
GSK Investigational Site
Bangkok, Thailand, 10330
United Kingdom
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G11 6NT
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G51 4TF
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G42 9TY
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
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00274690     History of Changes
Other Study ID Numbers: NKT102245
Study First Received: January 9, 2006
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Neurokinin-1 Receptor Antagonist
GW679769
Post-operative Nausea
NK-1 Receptor Antagonist
PONV
Post-discharge Nausea and Vomiting
PDNV
Vomiting

Additional relevant MeSH terms:
Nausea
Postoperative Nausea and Vomiting
Vomiting
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive
Casopitant
Neurokinin-1 Receptor Antagonists
Antiemetics
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014