Post Operative Nausea and Vomiting in surgical patients MedDRA version: 14.1 Level: LLT Classification code 10036901 Term: Prophylaxis against postoperative nausea and vomiting System Organ Class: 100000004865
Conditions
Interventions
Product Name: aprepitant
Product Code: MK-0869
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: APREPITANT
CAS Number: 170729-80-3
Current Sponsor code: MK-0869
Other descriptive n
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is birth (at least 37 weeks gestation and =3 kg of weight) to 17 years of age at the time of randomization. 2. Patient is scheduled to receive general anesthesia AND: Patients must have at least one of the following risk factors for PONV (in addition to receiving general anesthesia): o Surgery with an associated risk of PONV: tonsillectomy, adenoidectomy, strabismus surgery, dental surgery, hydrocelectomy, orchidopexy or herniorraphy –OR- o Operative procedure associated with PONV: intraoperative use or anticipated opioid administration within the first 24 following surgery. Are the trial subjects under 18? yes Number of subjects for this age range: 260 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient is undergoing emergency surgery for a life threatening condition. 2. Patient is scheduled to receive propofol for maintenance of anesthesia. (Note: propofol is permitted for induction of anesthesia). 3. Patient is expected to receive opioid antagonists (e.g., naloxone, naltrexone) or benzodiazepine antagonists (e.g., flumazenil) 4. Patient is scheduled to undergo cardiac or neurosurgery. 5. Patient has vomited within 24 hours prior to surgery. 6. Patient has an active infection (e.g., pneumonia), any uncontrolled disease (e.g., diabetic ketoacidosis, pre-existing gastrointestinal conditions/gastrointestinal obstruction) except for malignancy, or a history of any illness, which, in the opinion of the investigator, might confound the results of the study or pose unwarranted risk in administering study drug/comparator to the patient. 7. Patient has a nasogastric or oral gastric tube intra- or post-operatively for suctioning gastric contents (Note: nasogastric or oral gastric tube intra- or post-operatively may ONLY be used for feeding. Patients should be excluded if a nasogastric or oral gastric tube is routinely used for the type of surgery to be performed). 8. Patients with a know history of QT prolongation. 9. Patient is allergic to aprepitant, ondansetron or any 5-HT3 antagonist. 10. Patient is taking the anti-coagulant warfarin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate post-operative aprepitant plasma concentration profiles and pharmacokinetic parameters by population analysis including historical data (e.g. Cmax, Tmax, AUC0-8, t1/2, CL/F) in Dose 1, 2, 3 (Dose 4 if needed) obtained from pediatric patients from birth to 17 years of age administered oral aprepitant preoperatively. Safety: To evaluate the safety and tolerability of the administered dose(s) of aprepitant in pediatric patients from birth to 17 years of age.;Secondary Objective: No secondary objective;Primary end point(s): Pharmacokinetic endpoints are Cmax, Tmax, AUC0-8, t1/2 and CL/F estimated by population methods, including the use of historic data in the population modeling, in each age group for all aprepitant treatments. ;Timepoint(s) of evaluation of this end point: -30 to 60 minutes prior to aprepitant administration -2 to 4 hours post aprepitant administration -5 to 7 hours post aprepitant administration -8 to 10 hours post aprepitant administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): There are no secondary end points for this study.;Timepoint(s) of evaluation of this end point: There are no secondary end points for this study. | — |
Countries
Brazil, Canada, Chile, Czech Republic, Guatemala, Hungary, India, Italy, Mexico, Peru, Puerto Rico, Russian Federation, Spain, Turkey, Ukraine, United States
Contacts
Public ContactGlobal Clinical Trials Operations
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
Outcome results
None listed