Post-operative Nausea and Vomiting (PONV)Phase 3NCT06543966
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 Post-operative Nausea and Vomiting (PONV), run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd..
Trial summary
A randomized, double-blind, placebo-controlled, multi-center phase III study to compare the efficacy and safety of aprepitant injection and placebo in the prevention of post-operative nausea and vomiting (PONV)., Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post-operative Nausea and Vomiting (PONV)
- 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
- 486 participants
- Where
- No sites listed yet
- Study dates
- 28 Oct 2024to 28 Mar 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 and ≤75 years old; 18 < BMI≤30kg/m^2, body weight ≥45kg; laparoscopic gynecologic or abdominal surgery under general anesthesia that was expected to last at least 1 hour.
- expected or agreed to stay in the hospital for 24 hours or more after surgery;
Who cannot join
- diagnostic surgery; scheduled for postoperative transfer to an intensive care unit; requiring placement of a nasogastric or orogastric tube after surgery; Post-operative vomiting may pose significant risk;
Trial locations and contacts
No sites are listed yet.
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 in the Prevention of Post-operative Nausea and Vomiting
A randomized, double-blind, placebo-controlled, multi-center phase III study to compare the efficacy and safety of aprepitant injection and placebo in the prevention of post-operative nausea and vomiting (PONV).,
Read the detailed description
In this study, a randomized, double-blind, placebo-controlled multicenter study will be conducted to evaluate the efficacy and safety of aprepitant injection in the prevention of post-operative nausea and vomiting (PONV).
- Being tested
- Aprepitant Injection, Aprepitant Injection Placebo
- Medical subject headings
- 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(0mg） was given by a single intravenous injection, which was completed within 30 seconds
| Study group | Role | What they receive |
|---|---|---|
| Aprepitant Injection | Experimental | Before anesthesia induction, 4.4ml(32mg） was given by a single intravenous injection, which was completed within 30 seconds Receives: Drug: Aprepitant Injection |
| Placebo | Placebo comparator | Before anesthesia induction, 4.4ml(0mg）was given by a single intravenous injection, which was completed within 30 seconds 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
Secondary outcomes (7)
Proportion of participants who have no nausea in the 0 to 24 hours following the end of surgery
No nausea（defined as a visual analogue scale (VAS) nausea score < 1.）
Measured: 0-24 hours after the end of surgery
Proportion of participants who have significant nausea in the 0 to 24 hours following the end of surgery
Significant nausea（defined as a visual analogue scale (VAS) nausea score≥4）
Measured: 0-24 hours after the end of surgery
Proportion of participants who have no vomiting or retching in the 0 to 24 hours following the end of surgery
No vomiting or retching（Defined as whether or not use remedy treatment had no vomiting）
Measured: 0-24 hours after the end of surgery
Proportion of participants who use the remedial treatment in the 0 to 24 hours following the end of surgery
Measured: 0-24 hours after the end of surgery
Time to treatment failure in the 0 to 24 hours following the end of surgery
defined as the time to the first episode of vomiting (vomiting or retching) or the time to rescue therapy, whichever occurred first.
Measured: 0-24 hours after the end of surgery
Proportion of participants who have no vomiting or retching in the 0 to 48 hours following the end of surgery
No vomiting or retching（Defined as whether or not use remedy treatment had no vomiting）
Measured: 0-48 hours after the end of surgery
The time to the first episode of vomiting (vomiting or retching) in the 0 to 48 hours following the end of surgery
Measured: 0-48 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 posted9 Aug 2024
- Study start28 Oct 2024 (estimated)
- Primary completion28 Mar 2026 (estimated)
- Study completion28 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative Nausea and Vomiting (PONV)Studies of the same condition, open and under way.
- More trials run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.The sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parrallel Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 486 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543966
- Sponsor's protocol ID
- SYH9053-002
- Status last verified
- Aug 2024
- First submitted
- 17 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. 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 in the Prevention of Post-operative Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT06543966
- Acronym / sponsor ID
- SYH9053-002
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 486 participants (estimated)
- Lead sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Oct 2024 (estimated)
- Primary completion
- 28 Mar 2026 (estimated)
- Study completion
- 28 Mar 2026 (estimated)
- First posted
- 9 Aug 2024 (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.
A randomized, double-blind, placebo-controlled, multi-center phase III study to compare the efficacy and safety of aprepitant injection and placebo in the prevention of post-operative nausea and vomiting (PONV).,
Detailed description
In this study, a randomized, double-blind, placebo-controlled multicenter study will be conducted to evaluate the efficacy and safety of aprepitant injection in the prevention of post-operative nausea and vomiting (PONV).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parrallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Aprepitant Injection | Experimental | Drug: Aprepitant InjectionBefore anesthesia induction, 4.4ml(32mg） was given by a single intravenous injection, which was completed within 30 seconds |
| Placebo | Placebo comparator | Drug: Aprepitant Injection PlaceboBefore anesthesia induction, 4.4ml(0mg）was given by a single intravenous injection, which was completed within 30 seconds |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18 and ≤75 years old; 18 < BMI≤30kg/m^2, body weight ≥45kg; laparoscopic gynecologic or abdominal surgery under general anesthesia that was expected to last at least 1 hour.
- expected or agreed to stay in the hospital for 24 hours or more after surgery;
Key exclusion criteria (1 listed)
- diagnostic surgery; scheduled for postoperative transfer to an intensive care unit; requiring placement of a nasogastric or orogastric tube after surgery; Post-operative vomiting may pose significant risk;
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(0mg） was given by a single intravenous injection, which was completed within 30 seconds | Drug | 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)
7 secondary outcomes
Proportion of participants who have no nausea in the 0 to 24 hours following the end of surgery
Time frame: 0-24 hours after the end of surgery
Proportion of participants who have significant nausea in the 0 to 24 hours following the end of surgery
Time frame: 0-24 hours after the end of surgery
Proportion of participants who have no vomiting or retching in the 0 to 24 hours following the end of surgery
Time frame: 0-24 hours after the end of surgery
Proportion of participants who use the remedial treatment in the 0 to 24 hours following the end of surgery
Time frame: 0-24 hours after the end of surgery
Time to treatment failure in the 0 to 24 hours following the end of surgery
Time frame: 0-24 hours after the end of surgery
Proportion of participants who have no vomiting or retching in the 0 to 48 hours following the end of surgery
Time frame: 0-48 hours after the end of surgery
The time to the first episode of vomiting (vomiting or retching) in the 0 to 48 hours following the end of surgery
Time frame: 0-48 hours after the end of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aprepitant Injection in people with Post-operative Nausea and Vomiting (PONV), run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd..
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xiangdong chen, Doctor of Medicine(M.D.) (+86-027-85726300, xiangdongchen2013@163.com), or a site near the patient. 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 9 Aug 2024.