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
Study complete
Study complete
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:
Enrollment:
435
Primary completion date:
Not applicable
Observational study model:
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
Showing 1 - 6 of 42 Results
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
Study complete
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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