Status:
COMPLETED
Efficacy and Safety Study of Aprepitant Injection for Prevention of Post-operative Nausea and Vomiting
Lead Sponsor:
Qilu Pharmaceutical (Hainan) Co., Ltd.
Conditions:
Postoperative Nausea and Vomiting
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The goal of this Interventional study is to evaluate the efficacy and safety of Aprepitant Injection(QLG2174) for preventing PONV in Chinese patients.
Eligibility Criteria
Inclusion
- aged 18 to 70 years, with a body mass index (BMI) of 18-30 kg/m² and body weight≥45kg.
- laparoscopic gynecologic or abdominal surgery under general anesthesia (duration≥1 hour and postoperative hospitalization ≥24 hours), with anesthesia maintained using sevoflurane and remifentanil (propofol maintenance was prohibited);
- had≥2 risk factors of PONV; expected to use postoperative opioid within 24 hours after surgery;
- American Society of Anesthesiologists (ASA) physical status class I-III.
Exclusion
- planned intrathoracic, transplant, or central nervous system surgeries;
- diagnostic-only procedures;
- use of local/regional anesthesia (e.g., neuraxial/nerve blocks);
- postoperative intensive care unit (ICU) transfer;
- preoperative nasogastric/orogastric tube placement (from screening through 24 hours postoperatively)
- nausea, vomiting, retching, or organic disease-related emesis (e.g., intestinal obstruction) within 24 hours preoperatively; history of malignancy, epilepsy, or vestibular dysfunction;
- hypersensitivity to aprepitant;
- recent use of aprepitant/NK1 antagonists (within 2 weeks prior to randomization), antiemetics (including 5-HT3 antagonists, corticosteroids; within 1 week), strong CYP3A4 inhibitors/substrates (within 1 week), CYP3A4 inducers (within 4 weeks), or warfarin (within 2 weeks);
- clinically significant laboratory abnormalities (ALT/AST ≥2×upper limit of normal \[ULN\], total bilirubin ≥1.5×ULN, creatinine ≥1.5×ULN, hemoglobin ≤90 g/L)
Key Trial Info
Start Date :
February 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2024
Estimated Enrollment :
518 Patients enrolled
Trial Details
Trial ID
NCT06932107
Start Date
February 2 2024
End Date
June 5 2024
Last Update
April 23 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, China