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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06932107

Enrollment

518

Registered

2025-04-17

Start date

2024-02-02

Completion date

2024-06-05

Last updated

2025-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea and Vomiting

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.

Interventions

DRUGAprepitant Injection

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

DRUGAprepitant Injection Placebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026