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

April 17, 2025 updated by: Qilu Pharmaceutical (Hainan) Co., Ltd.

A Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Aprepitant Injection(QLG2174) in the Prevention of Post-operative Nausea and Vomiting

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

518

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Wuhan, China
        • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aprepitant Injection
Drug: Aprepitant Injection
Before anesthesia induction, 4.4ml(32mg） was given by a single intravenous injection, which was completed within 30 seconds
Experimental: Aprepitant Injection Placebo
Drug: Aprepitant Injection Placebo
Before anesthesia induction, 4.4ml was given by a single intravenous injection, which was completed within 30 seconds

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response (CR) rates over 24 hours after the end of surgery
Time Frame: 0-24 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Pharmaceutical (Hainan) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2024

Primary Completion (Actual)

May 28, 2024

Study Completion (Actual)

June 5, 2024

Study Registration Dates

First Submitted

April 10, 2025

First Submitted That Met QC Criteria

April 10, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Actual)

April 23, 2025

Last Update Submitted That Met QC Criteria

April 17, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QLG2174-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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