Study Of An NK-1 Anti-Emetic Medication For The Prevention Of Post-Operative Nausea And Vomiting In Female Patients
Trial overview
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
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
Participation criteria
- Inclusion Criteria:
- known risk factors for PONV.
- Inclusion Criteria:
- known risk factors for PONV.
- Undergoing gynecological or gallbladder surgery.
Trial location(s)
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
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.