Efficacy and Safety Study of Aprepitant Injection for Prevention of Post-operative Nausea and Vomiting

Qilu Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Postoperative Nausea and Vomiting

Treatments

Drug: Aprepitant Injection

Drug: Aprepitant Injection Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06932107

QLG2174-301

Details and patient eligibility

About

The goal of this Interventional study is to evaluate the efficacy and safety of Aprepitant Injection(QLG2174) for preventing PONV in Chinese patients.

Enrollment

518 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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)