Postoperative Nausea and Vomiting MedDRA version: 8.1 Level: LLT Classification code 10036238
Conditions
Interventions
Product Name: EMEND
Product Code: MK-0869
Pharmaceutical Form: Capsule*
INN or Proposed INN: aprepitant
Concentration unit: mg milligram
Sponsors
Merck & Co., Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient is at least 18 years of age. Patient is scheduled to undergo open abdominal surgery or laparoscopically-assisted vaginal hysterectomy requiring overnight hospital stay (24-hour hospital stay after surgery). Patient is scheduled to receive general anesthesia, including induction agents, narcotics, neuromuscular blocking agents, and maintenance with nitrous oxide (50 to 70%) with volatile anesthetic. Patient is scheduled to receive postoperative opioids by IM or IV route, or by IV patient-controlled analgesia. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient is expected to receive propofol for maintenance of anesthesia. Placement of a nasogastric or oral gastric tube intra or postoperatively (patients should be excluded if these are routinely used for the type of surgery to be performed.) Patient is expected to receive neuroaxial anesthesia/analgesia (patients should be excluded if neuroaxial anesthesia/analgesia is routinely used for the type of surgery to be performed.) Please see Protocol for additional criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): No Vomiting (from 0 to 24 hours post operatively) Complete Response (No Vomiting and no use of Rescue; from 0 to 24 hours postoperatively) ; Main Objective: 1. To demonstrate that aprepitant 40 mg is superior to ondansetron 4 mg IV with respect to the proportion of patients with No Vomiting in the 24 hours following end of surgery. 2. To demonstrate that aprepitant 40 mg is non-inferior to ondansetron with respect to the proportion of patients with Complete Response in the 24 hours following end of surgery. If non-inferiority is established the following will also be evaluated: Aprepitant 40 mg is superior to ondansetron with respect to the proportion of patients with Complete Response in the 24 hours following end of surgery. 3. To evaluate the safety and tolerability of aprepitant 40 mg in patients undergoing surgery. ; Secondary Objective: 1. To demonstrate aprepitant 40 mg superior to ondansetron with respect to proportion of patients with No Vomiting in48 hours following end of surgery. 2. To demonstrate aprepitant 40 mg non-inferior to ondansetron with respect to proportion of patients with No Vomiting and No Nausea in24 hours following end of surgery. If non-inferiority is established, the following will also be evaluated: Aprepitant is superior to ondansetron with respect to the proportion of patients with No Vomiting and No Nausea in 24 hours following end of surgery. 3. To demonstrate aprepitant 40 mg superior to ondansetron with respect to time to first vomiting episode in the 48 hours following end of surgery. 4. To demonstrate aprepitant 40 mg superior to ondansetron with respect to number of vomiting episodes in 24 hours following end of surgery. 5. To demonstrate aprepitant superior to ondansetron with respect to peak nausea scores in 24 hours follow | — |
Countries
Austria, Lithuania
Outcome results
None listed