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

NCT06932107 | Completed Phase 3

• 1 other identifier: QLG2174-301
• Study Type: interventional
• Target: 518
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Complete response (CR) rates over 24 hours after the end of surgery

  Complete response (defined as no emetic episodes and no use of rescue therapy

  0-24 hours after the end of surgery

Study Arms (2)

Aprepitant Injection

EXPERIMENTAL

Drug: Aprepitant Injection

Aprepitant Injection Placebo

EXPERIMENTAL

Drug: Aprepitant Injection Placebo

Interventions

Aprepitant Injection DRUG

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

Aprepitant Injection

Aprepitant Injection Placebo DRUG

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

Aprepitant Injection Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Qilu Pharmaceutical (Hainan) Co., Ltd.: lead

Study Sites (1)

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

Wuhan, China

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 17, 2025
• Study Start: February 2, 2024
• Primary Completion: May 28, 2024
• Study Completion: June 5, 2024
• Last Updated: April 23, 2025

Record last verified: 2025-04

Locations

CN (1)