Last updated: 11/07/2018 17:45:07
Casopitant And ZOFRAN To Prevent Post Operative Nausea And Vomiting In Women
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 the 30 mg Intravenous Formulation of the Neurokinin-1 Receptor Antagonist GW679769 for 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:
Not applicable
Allocation:
Randomized
Primary outcomes:
Number of participants who achieved a complete response
Timeframe: Up to 24 hours
Secondary outcomes:
The severity of nausea experienced by participants in each cohort during the 0–24 hours, 24-48 hours and 0-48 hours periods, as assessed by an 11-point, linear, numerical rating scale referred to as a “0–10 Likert scale”
Timeframe: 0–24 hours, 24-48 hours and 0-48 hours
Number of Participants According to Severity of Nausea in Each Cohort During the 0–24 hours, 24-48 hours and 0-48 hours Periods, as Assessed by a Categorical Scale (None, Mild, Moderate or Severe), as Defined in the Protocol
Timeframe: 0–24 hours, 24-48 hours and 0-48 hours
Number of participants with first emetic event
Timeframe: Up to 48 hours
Number of participants with first antiemetic rescue medication
Timeframe: Up to 48 hours
Participant satisfaction with the prophylactic antiemetic regimens, as assessed by participant satisfaction assessments in the participant diary
Timeframe: Up to 48 hours
Participant willingness of participants to use the same treatment regimen for future surgical procedures, as assessed by participant satisfaction assessments in the participant diary
Timeframe: Up to 48 hours
Number of participants with chemistry data outside the reference range
Timeframe: Baseline (Screening), Day 1/2 and Days 6-14
Number of participants with hematology data outside the reference range
Timeframe: Baseline (Screening), Day 1/2 and Days 6-14
Time to Awakening From Anesthesia
Timeframe: Up to 24 hours
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Up to Days 6–14
Interventions:
Drug: Placebo
Drug: ondansetron HCL
Drug: GW679769
Enrollment:
514
Observational study model:
Not applicable
Primary completion date:
2006-13-07
Time perspective:
Not applicable
Clinical publications:
Chung, F; Singla, S, Grenier, A; Kutsogiannis, D; Kett, A; Pergolizzi, J; Russo, M. A Phase III Study to Evaluate Efficacy and Safety of IV Casopitant for Prevention of PONV in High-Risk Female Patients. Eur J Anaesthesiol
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 (postoperative nausea and vomiting) and/or motion sickness.
- Have not smoked for the last 6 months.
- Pregnant or breastfeeding.
- Have certain pre-existing medical conditions or take certain medications.
Inclusion and exclusion criteria
Inclusion criteria:
- History of PONV (postoperative nausea and vomiting) and/or motion sickness.
- Have not smoked for the last 6 months.
- Having certain abdominal, breast, thyroid or shoulder surgery.
Exclusion criteria:
- Pregnant or breastfeeding.
- Have certain pre-existing medical conditions or take certain medications.
Trial location(s)
Location
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24105
Status
Study Complete
Location
GSK Investigational Site
Neubrandenburg, Mecklenburg-Vorpommern, Germany, 17036
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New Hyde Park, New York, United States, 11040
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Melbourne, Florida, United States, 32901
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Winchester, Virginia, United States, 22601
Status
Study Complete
Location
GSK Investigational Site
Fairhope, Alabama, United States, 36532
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
Location
GSK Investigational Site
Ludwigshafen, Rheinland-Pfalz, Germany, 67063
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60637
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98195
Status
Study Complete
Location
GSK Investigational Site
West Palm Beach, Florida, United States, 33409
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21229-5299
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Glendale, California, United States, 91206
Status
Study Complete
Location
GSK Investigational Site
Sheung Shui, New Territories, Hong Kong
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Mobile, Alabama, United States, 36608
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Arcadia, California, United States, 91007
Status
Study Complete
Location
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79110
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10038
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kansas City, Kansas, United States, 66160
Status
Study Complete
Location
GSK Investigational Site
Laguna Hills, California, United States, 92653
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Sherbrooke, Québec, Canada, J1H 5N4
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45208
Status
Study Complete
Location
GSK Investigational Site
Montgomery, Alabama, United States, 36106
Status
Study Complete
Location
GSK Investigational Site
Royal Oak, Michigan, United States, 48073
Status
Study Complete
Location
GSK Investigational Site
Boca Raton, Florida, United States, 33067
Status
Study Complete
Location
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19055
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Charlottesville, Virginia, United States, 22908
Status
Study Complete
Location
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18059
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wismar, Mecklenburg-Vorpommern, Germany, 23966
Status
Study Complete
Location
GSK Investigational Site
Mineola, New York, United States, 11501
Status
Study Complete
Location
GSK Investigational Site
Pasadena, California, United States, 91105
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
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2006-13-07
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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