Postoperative Nausea and VomitingPhase 3NCT06932107
Efficacy and Safety Study of Aprepitant Injection for Prevention of Post-operative Nausea and Vomiting
A Phase 3 study testing Aprepitant Injection in people with Postoperative Nausea and Vomiting, run by Qilu Pharmaceutical (Hainan) Co., Ltd. at 1 site in China.
Trial summary
The goal of this Interventional study is to evaluate the efficacy and safety of Aprepitant Injection(QLG2174) for preventing PONV in Chinese patients. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Aprepitant Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 518 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2024to 5 Jun 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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)
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan
About this study
Official title: 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.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Aprepitant Injection, Aprepitant Injection Placebo
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aprepitant InjectionDrug
Before anesthesia induction, 4.4ml(32mg） was given by a single intravenous injection, which was completed within 30 seconds
Aprepitant Injection PlaceboDrug
Before anesthesia induction, 4.4ml was given by a single intravenous injection, which was completed within 30 seconds
| Study group | Role | What they receive |
|---|---|---|
| Aprepitant Injection | Experimental | Not described Receives: Drug: Aprepitant Injection |
| Aprepitant Injection Placebo | Experimental | Not described Receives: Drug: Aprepitant Injection Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0-24 hours after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start2 Feb 2024
- Primary completion28 May 2024
- Study completion5 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 518 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical (Hainan) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932107
- Sponsor's protocol ID
- QLG2174-301
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06932107
- Acronym / sponsor ID
- QLG2174-301
- Conditions
- Postoperative Nausea and Vomiting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 518 participants (actual)
- Lead sponsor
- Qilu Pharmaceutical (Hainan) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this Interventional study is to evaluate the efficacy and safety of Aprepitant Injection(QLG2174) for preventing PONV in Chinese patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aprepitant Injection | Experimental | Drug: Aprepitant Injection |
| Aprepitant Injection Placebo | Experimental | Drug: Aprepitant Injection Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aprepitant InjectionBefore anesthesia induction, 4.4ml(32mg） was given by a single intravenous injection, which was completed within 30 seconds | Drug | Aprepitant Injection |
| Aprepitant Injection PlaceboBefore anesthesia induction, 4.4ml was given by a single intravenous injection, which was completed within 30 seconds | Drug | Aprepitant Injection Placebo |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aprepitant Injection in people with Postoperative Nausea and Vomiting, run by Qilu Pharmaceutical (Hainan) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response (CR) rates over 24 hours after the end of surgery (time frame: 0-24 hours after the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.