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CompletedNCT06932107Updated Apr 23, 2025

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

A Phase 3 interventional study of Aprepitant Injection and Aprepitant Injection Placebo in Postoperative Nausea and Vomiting, sponsored by Qilu Pharmaceutical (Hainan) Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-23.

Sponsored by Qilu Pharmaceutical (Hainan) Co., Ltd. (part of Qilu Pharmaceutical Co., Ltd.) · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Feb 2024, registered Apr 2025).
Phase
Phase 3
Study type
Interventional
Enrollment
518
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Postoperative Nausea and Vomiting
03

In context

Postoperative Nausea and Vomiting

638 studies on the registry are indexed under Postoperative Nausea and Vomiting; 110 are open to participants now.

This study's enrollment of 518 is above the median of 112 across 529 interventional studies indexed under Postoperative Nausea and Vomiting.

Browse Postoperative Nausea and Vomiting studies →

Lead sponsor

Qilu Pharmaceutical (Hainan) Co., Ltd. is the lead sponsor of 8 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • aged 18 to 70 years, with a (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;
  • (ASA) physical status class I-III.

Exclusion criteria

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 , epilepsy, or vestibular dysfunction;
  • to aprepitant;
  • recent use of aprepitant/NK1 antagonists (within 2 weeks prior to randomization), antiemetics (including 5-HT3 antagonists, ; within 1 week), strong inhibitors/substrates (within 1 week), CYP3A4 inducers (within 4 weeks), or warfarin (within 2 weeks);
  • laboratory abnormalities (/AST ≥2× [ULN], total ≥1.5×ULN, creatinine ≥1.5×ULN, ≤90 g/L)
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
518 participants (actual)

Study arms

  • Experimental
    Aprepitant Injection

    Drug: Aprepitant Injection

  • Experimental
    Aprepitant Injection Placebo

    Drug: Aprepitant Injection Placebo

Interventions

  • 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

06

What researchers measure

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

    Time frame: 0-24 hours after the end of surgery

07

Study locations

1 site
  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
    Wuhan, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2024 to primary completion in May 2024, 3 months.

Of 22 phase 3 interventional studies under Postoperative Nausea and Vomiting, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 27. This study's 3 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 10, 2025
First posted
Apr 17, 2025
StartActual
Feb 2, 2024
Primary completionActual
May 28, 2024
CompletionActual
Jun 5, 2024
Last update
Apr 23, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06932107
Responsible party
Sponsor
First posted
Apr 17, 2025
Start date
Feb 2, 2024
Primary completion
May 28, 2024
Completion
Jun 5, 2024
Last update
Apr 23, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Aprepitant

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