Last updated: 11/04/2018 09:42:58
Study Of An NK-1 Anti-Emetic Medication For The Prevention Of Post-Operative Nausea And Vomiting In Female Patients
GSK study ID
NKO101287
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Phase II Multicenter, Dose Ranging Study on the Safety and Antiemetic Efficacy of One Day Intraveous dosing of GW597599 administered with Ondansetron HCL in a female subjects undergoing surgical procedures of high emetogenic risk
Trial description: The purpose of this study is to determine the effectiveness of this medication in preventing nausea and vomiting in female patients at risk for post-operative nausea and vomiting (PONV).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Number of participants who achieved a complete antiemetic response during the first 24 hour evaluation period following the emergence from anesthesia
Timeframe: Up to 24 hours
Secondary outcomes:
Number of participants who achieved a complete antiemetic response during each subsequent 24 hour evaluation period (up to 120 hours) following the emergence from anesthesia
Timeframe: Up to 120 hours
Number of participants who experienced Nausea during the 2-, 6-, and 24-hour evaluation periods following the emergence from anesthesia, as assessed by a visual analogue scale (VAS)
Timeframe: Up to 24 hours
Number of participants who experienced Nausea at each subsequent 24-hour evaluation period (up to 120 hours) following the emergence from anesthesia, as assessed by a VAS
Timeframe: Up to 120 hours
The impact on daily life activities in participants during the 120-hour evaluation period following the emergence from anesthesia, as assessed by a Functional Living Index - Emesis (FLIE) questionnaire
Timeframe: Up to 120 hours
Number of participants who were satisfied with the control of Post-Operative or discharge Nausea and Vomiting (PONV/PDNV)
Timeframe: Up to 120 hours
Number of Participants Who Were Willing to Participate to Use the Same Antiemetic Drug Treatment Regimen for Subsequent Surgical Procedures
Timeframe: Up to 120 hours
Number of participants who experienced pain during the 2-, 6-, and 24-hour evaluation periods, and each subsequent 24 hour evaluation period (up to 120 hours), following the emergence from anesthesia, as assessed by a VAS
Timeframe: up to 120 hours
Number of participants who experienced complete protection during the first 24-hour and subsequent evaluation periods up to 120 hours following the emergence from anesthesia
Timeframe: up to 120 hours
Number of participants who experienced total control during the first 24-hour and subsequent evaluation periods up to 120 hours owing the emergence from anesthesia
Timeframe: up to 120 hours
Number of participants with emesis
Timeframe: Up to 120 hours
Number of participants who used rescue medication
Timeframe: Up to 120 hours
Summary of physical examination
Timeframe: Screening (Within 21 days prior to the day of surgery or the same day as surgery)
Vital Signs- Mean Systolic and Diastolic blood pressure at indicated time points
Timeframe: Day 1(prior to study medication and prior to discharge from the surgical facility or at the end of the 24-hour follow-up assessment )
Vital Signs-Mean Heart rate at indicated time points
Timeframe: Day 1(prior to study medication and prior to discharge from the surgical facility or at the end of the 24-hour follow-up assessment )
Vital Signs- Mean Respiration rate at indicated time points
Timeframe: Day 1(prior to study medication and prior to discharge from the surgical facility or at the end of the 24-hour follow-up assessment)
Number of participants with abnormal electrocardiogram (ECG) findings
Timeframe: Screening (within 21 days prior to the day of surgery) and Day 1 (prior to discharge from the surgical facility or at the end of the 24-hour
Number of participants with Chemistry Data Outside the Reference Range
Timeframe: Up to 120 hours
Number of participants with Hematology Data Outside the Reference Range
Timeframe: Up to 120 hours
Mean time to awakening from anesthesia and time to readiness for discharge
Timeframe: Up to 120 hours
Number of participants with adverse events (Aes) and serious adverse events (SAEs)
Timeframe: Up to 120 hours
Population pharmacokinetic/ pharmacodynamic (PK/PD) parameters for vestipitant, including an assessment of significant covariates
Timeframe: Pre-dose, 30, 60, 90 minutes and 3-6, 8-14 and 18-25 hours on Day 1
Summary of the use of medications to control post-surgical pain
Timeframe: Up to 120 hours
Interventions:
Drug: GW597599 oral
Drug: Ondansetron HCl
Drug: GW597599 IV
Drug: GW597599 oral Placebo
Drug: GW597599 IV Placebo
Enrollment:
624
Observational study model:
Not applicable
Primary completion date:
2006-11-07
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Postoperative Nausea and Vomiting
Product
ondansetron, vestipitant
Collaborators
Not applicable
Study date(s)
December 2004 to July 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female
Age
18 - 55 years
Accepts healthy volunteers
No
- Inclusion Criteria:
- known risk factors for PONV.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria:
- known risk factors for PONV.
- Undergoing gynecological or gallbladder surgery.
Trial location(s)
Location
GSK Investigational Site
Laguna Hills, California, United States, 95660
Status
Study Complete
Location
GSK Investigational Site
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Subiaco, Western Australia, Australia, 6008
Status
Study Complete
Location
GSK Investigational Site
Dallas, Texas, United States, 75390-9135
Status
Study Complete
Location
GSK Investigational Site
Boca Raton, Florida, United States, 33067
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90048
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Oshawa, Ontario, Canada, L1G 2B9
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Northampton, Northamptonshire, United Kingdom, NN1 5BD
Status
Study Complete
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 8380456
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60611
Status
Study Complete
Location
GSK Investigational Site
St Leonards, New South Wales, Australia, 2065
Status
Study Complete
Location
GSK Investigational Site
Pasadena, California, United States, 91109
Status
Study Complete
Location
GSK Investigational Site
Ringwood East, Victoria, Australia, 3128
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19141
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New York, New York, United States, 10021
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ostrava - Poruba, Czech Republic, 708 52
Status
Study Complete
Location
GSK Investigational Site
Kingston, Ontario, Canada, K7L 5C2
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
Status
Study Complete
Location
GSK Investigational Site
Albany, New York, United States, 12208
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Plymouth, Devon, United Kingdom, PL6 8DH
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chelmsford, Essex, United Kingdom, CM1 7ET
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99204
Status
Study Complete
Location
GSK Investigational Site
Westmead, New South Wales, Australia, 2145
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90089
Status
Study Complete
Location
GSK Investigational Site
Durham, North Carolina, United States, 27710
Status
Study Complete
Location
GSK Investigational Site
Glendale, California, United States, 91206
Status
Study Complete
Location
GSK Investigational Site
Charlottetown, Prince Edward Island, Canada, C1A 8T5
Status
Study Complete
Location
GSK Investigational Site
Victoria, British Columbia, Canada, V8Z 6R5
Status
Study Complete
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2006-11-07
Actual study completion date
2006-11-07
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.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website