A Study To Evaluate An NK-1 Antiemetic For The Prevention Of Post Operative Nausea And Vomiting

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00108095
First received: April 13, 2005
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

This study is looking at a range of doses of this NK-1 receptor antagonist drug, for both safety and effectiveness in prevention PONV


Condition Intervention Phase
Postoperative Nausea and Vomiting
Nausea and Vomiting, Postoperative
Drug: intravenous ondansetron
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of subjects who achieve a complete response (defined as no vomiting, no retching, no rescue therapy, and no premature discontinuation from the study) during the first 24 hour evaluation period following emergence from anesthesia

Secondary Outcome Measures:
  • Number of subjects who achieve a complete response during each subsequent 24 hour evaluation period (up to 120 hours)following the emergence from anesthesia
  • The extent of nausea experienced by subjects.

Estimated Enrollment: 665
Study Start Date: October 2004
Intervention Details:
    Drug: intravenous ondansetron
    Other Name: intravenous ondansetron
Detailed Description:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of the Oral Neurokinin-1 Receptor Antagonist, GW67969, When Administered With Intravenous Ondansetron Hydrochloride for the Prevention of Post-Operative Nausea and Vomiting (PONV) and Post-Discharge Nausea and Vomiting (PDNV) in Female Subjects With Known Risk Factors for PONV Who Are Undergoing 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:

  • Females age 18-55
  • Laparoscopic/laparotomic gynecological procedure of laparoscopic gallbladder removal

Exclusion criteria:

  • Pregnant or breastfeeding
  • Post-menopausal
  • Not undergoing general anesthesia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00108095

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Montgomery, Alabama, United States, 36106
United States, Arizona
GSK Investigational Site
Phoenix, Arizona, United States, 85032
United States, California
GSK Investigational Site
Arcadia, California, United States, 91007
GSK Investigational Site
Duarte, California, United States, 91010
GSK Investigational Site
Glendale, California, United States, 91206
GSK Investigational Site
Laguna Hills, California, United States, 92653
GSK Investigational Site
Loma Linda, California, United States, 92354
GSK Investigational Site
Pasadena, California, United States, 91109
GSK Investigational Site
San Diego, California, United States, 92123
GSK Investigational Site
Stanford, California, United States, 94305
United States, Florida
GSK Investigational Site
Naples, Florida, United States, 34108
GSK Investigational Site
Pensacola, Florida, United States, 32504
United States, Georgia
GSK Investigational Site
Alpharetta, Georgia, United States, 30005
United States, Kansas
GSK Investigational Site
Hutchinson, Kansas, United States, 67502
GSK Investigational Site
Kansas City, Kansas, United States, 66160
United States, Louisiana
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70806
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21229-5299
United States, Mississippi
GSK Investigational Site
Jackson, Mississippi, United States, 39202
United States, New Jersey
GSK Investigational Site
New Brunswick, New Jersey, United States, 8903
United States, New York
GSK Investigational Site
New York, New York, United States, 10025
GSK Investigational Site
New York, New York, United States, 10016
United States, North Carolina
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
GSK Investigational Site
Charleston, South Carolina, United States, 29425
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77030
GSK Investigational Site
Houston, Texas, United States, 77054
GSK Investigational Site
Houston, Texas, United States, 77024
GSK Investigational Site
San Antonio, Texas, United States, 78240
United States, Virginia
GSK Investigational Site
Winchester, Virginia, United States, 22601
United States, Washington
GSK Investigational Site
Wenatchee, Washington, United States, 98801
Belgium
GSK Investigational Site
Aalst, Belgium, 9300
GSK Investigational Site
Braasschaat, Belgium, 2930
GSK Investigational Site
Bruxelles, Belgium, 1020
Canada, Alberta
GSK Investigational Site
Calgary, Alberta, Canada, T2N 2T9
GSK Investigational Site
Edmonton, Alberta, Canada, T5H 3V9
Canada, British Columbia
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 3C6
GSK Investigational Site
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Newfoundland and Labrador
GSK Investigational Site
Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
GSK Investigational Site
Hamilton, Ontario, Canada, L8N 3Z5
GSK Investigational Site
London, Ontario, Canada, N6A 4G5
GSK Investigational Site
London, Ontario, Canada, N6A 4V2
GSK Investigational Site
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H3A 1A1
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1H 5N4
GSK Investigational Site
Ste-Foy, Quebec, Canada, G1V 4G2
Canada
GSK Investigational Site
Quebec, Canada, G1L 3L5
Germany
GSK Investigational Site
Marburg, Hessen, Germany, 35043
GSK Investigational Site
Aachen, Nordrhein-Westfalen, Germany, 52074
GSK Investigational Site
Koblenz, Rheinland-Pfalz, Germany, 56073
Hungary
GSK Investigational Site
Győr, Hungary, 9023
GSK Investigational Site
Kistarcsa, Hungary, 2143
GSK Investigational Site
Miskolc, Hungary, 3529
GSK Investigational Site
Székesfehérvár, Hungary, 8001
Spain
GSK Investigational Site
Cadiz, Spain, 11009
GSK Investigational Site
Cartagena, Spain, 30203
GSK Investigational Site
Madrid, Spain, 28034
GSK Investigational Site
Santiago de Compostela, Spain, 15706
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00108095     History of Changes
Other Study ID Numbers: NKT102260
Study First Received: April 13, 2005
Last Updated: November 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
emesis
nausea
post operative nausea and vomiting
vomiting
PONV

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on April 23, 2014