Last updated: 11/04/2018 09:44:59
Casopitant (oral) And ZOFRAN To Prevent Postoperative Nausea And Vomiting In Women
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Phase III, Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of 50mg Oral Dosing with the Neurokinin-1 Receptor Antagonist GW679769 for the Prevention of Postoperative Nausea and Vomiting in Female Subjects at High Risk for Emesis
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Rates of vomiting and retching
Timeframe: after surgery
Secondary outcomes:
Rates of nausea. Blood test results.
Timeframe: after surgery
Interventions:
Drug: GW679769 (casopitant)
Enrollment:
482
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Altorjay A, Melson T, Chinachoti T, Kett A, Aqua K, Levin J, Blackburn LM, Lane S, Pergolizzi JV. Casopitant and Ondansetron for Postoperative Nausea and Vomiting Prevention in Women at High Risk for Emesis: A Phase 3 Study. [Arch Surg]. 2011;146(2):201-206.
Medical condition
Nausea and Vomiting, Postoperative
Product
casopitant
Collaborators
Not applicable
Study date(s)
March 2006 to July 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
No
- History of PONV and/or motion sickness.
- Have not smoked for the last 6 months.
- Pregnant or breastfeeding.
- Taking certain medications.
Inclusion and exclusion criteria
Inclusion criteria:
- History of PONV and/or motion sickness.
- Have not smoked for the last 6 months.
- Having certain types of abdominal, breast or shoulder surgeries.
Exclusion criteria:
- Pregnant or breastfeeding.
- Taking certain medications.
- Have certain pre-existing medical conditions.
Trial location(s)
Location
GSK Investigational Site
Jackson, Mississippi, United States, 39202
Status
Study Complete
Location
GSK Investigational Site
Sheffield, Alabama, United States, 35660
Status
Study Complete
Location
GSK Investigational Site
Livingston, West Lothian, United Kingdom, EH54 6PP
Status
Study Complete
Location
GSK Investigational Site
New Brunswick, New Jersey, United States, 8903
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10025
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19102
Status
Study Complete
Location
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G12 0YN
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Anderson, Indiana, United States, 46011
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85032
Status
Study Complete
Location
GSK Investigational Site
Boynton Beach, Florida, United States, 33437
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99204
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New York, New York, United States, 10016
Status
Study Complete
Location
GSK Investigational Site
Aachen, Nordrhein-Westfalen, Germany, 52074
Status
Study Complete
Location
GSK Investigational Site
Montgomery, Alabama, United States, 36106
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15232
Status
Study Complete
Location
GSK Investigational Site
Bronx, New York, United States, 10467
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Charlottetown, Prince Edward Island, Canada, C1A 8T5
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32216
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Antonio, Texas, United States, 78240
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Altoona, Pennsylvania, United States, 16602
Status
Study Complete
Location
GSK Investigational Site
New Brunswick, New Jersey, United States, 08901
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Melbourne, Florida, United States, 32901
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90033
Status
Study Complete
Location
GSK Investigational Site
Grand Rapids, Michigan, United States, 49503
Status
Study Complete
Location
GSK Investigational Site
Pensacola, Florida, United States, 32504
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V6Z 1Y6
Status
Study Complete
Location
GSK Investigational Site
Koblenz, Rheinland-Pfalz, Germany, 56073
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-13-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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