Last updated: 11/04/2018 09:44:19
Post-Operative Nausea And Vomiting Study In Female Patients
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Multicenter, Randomised, 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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
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.
Timeframe: 72 Hours
Secondary outcomes:
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.
Timeframe: 120 Hours
Interventions:
Drug: GW679769
Enrollment:
435
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Postoperative Nausea and Vomiting
Product
casopitant, ondansetron
Collaborators
Not applicable
Study date(s)
February 2005 to August 2005
Type
Interventional
Phase
2
Participation criteria
Sex
Female
Age
18 - 55 years
Accepts healthy volunteers
No
- Known, specified risk factors for PONV (post operative nausea and vomiting)
- Undergoing gynecologic or gallbladder surgery.
- pregnant or breastfeeding
- post-menopausal
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
West Palm Beach, Florida, United States, 33409
Status
Study Complete
Location
GSK Investigational Site
Camden, New Jersey, United States, 08103-1489
Status
Study Complete
Location
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G11 6NT
Status
Study Complete
Location
GSK Investigational Site
Royal Oak, Michigan, United States, 48073
Status
Study Complete
Location
GSK Investigational Site
Melbourne, Florida, United States, 32901
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Livingston, West Lothian, United Kingdom, EH54 6PP
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60637
Status
Study Complete
Location
GSK Investigational Site
Edinburgh, Midlothian, United Kingdom, EH16 4SA
Status
Study Complete
Location
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G51 4TF
Status
Study Complete
Location
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G42 9TY
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98195
Status
Study Complete
Location
GSK Investigational Site
Grand Rapids, Michigan, United States, 49525
Status
Study Complete
Location
GSK Investigational Site
San Francisco, California, United States, 94115
Status
Study Complete
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
2005-23-08
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.
Additional information about the trial
Additional information
Not applicable
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