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

Phase 3

Completed

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: Aprepitant Injection; Drug: Aprepitant Injection Placebo

• Registration Number: NCT06932107
• Lead Sponsor: Qilu Pharmaceutical (Hainan) Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-02
• Primary Completion: 2024-05-28
• Study Completion: 2024-06-05
• Status Verified: 2025-04
• Study First Submitted: 2025-04-10
• Study First Submitted QC: 2025-04-10
• Study First Posted: 2025-04-17
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 518

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aprepitant Injection	Aprepitant Injection	-
Aprepitant Injection Placebo	Aprepitant Injection Placebo	-

Primary Outcome Measures

Name	Time	Method
Complete response (CR) rates over 24 hours after the end of surgery	0-24 hours after the end of surgery	Complete response (defined as no emetic episodes and no use of rescue therapy

Trial Locations

Locations (1)

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology; 🇨🇳 Wuhan, China