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

NCT ID: NCT06932107

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 518 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-02
• Study Completion Date: 2024-06-05

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.

Conditions

Postoperative Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Aprepitant Injection

Group Type: EXPERIMENTAL

Aprepitant Injection

Intervention Type: DRUG

Before anesthesia induction, 4.4ml(32mg） was given by a single intravenous injection, which was completed within 30 seconds

Aprepitant Injection Placebo

Group Type: EXPERIMENTAL

Aprepitant Injection Placebo

Intervention Type: DRUG

Before anesthesia induction, 4.4ml was given by a single intravenous injection, which was completed within 30 seconds

Interventions

Aprepitant Injection

Before anesthesia induction, 4.4ml(32mg） was given by a single intravenous injection, which was completed within 30 seconds

Intervention Type: DRUG

Aprepitant Injection Placebo

Before anesthesia induction, 4.4ml was given by a single intravenous injection, which was completed within 30 seconds

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Qilu Pharmaceutical (Hainan) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, , China

Countries

China

Other Identifiers

QLG2174-301

Identifier Type: -

Identifier Source: org_study_id