PONVPhase 3NCT05822713
A Comparison of the Efficacy of Amisulpride and Placebo in the Prevention of PONV in Patients at Moderate-to-high Risk of PONV.
A Phase 3 study testing Amisulpride in people with PONV, run by Qilu Pharmaceutical (Hainan) Co., Ltd..
Trial summary
A comparison of the efficacy of Amisulpride and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- PONV
- What is being tested?
- Amisulpride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 516 participants
- Where
- No sites listed yet
- Study dates
- 29 Apr 2023to 31 Dec 2023
- 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
- Participant understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent.
- Male or female patients ≥ 18 years of age and ≤75 years of age.
- 18<BMI≤30kg/m^2，And weigh more than 45kg
- Patients undergoing elective surgery(laparoscopic gynecological or abdominal surgery) under general anaesthesia requiring，and inhalation anesthesia is maintained for more than 1 hour, but patients who receive purely diagnostic surgery cannot be enrolled;
- Patients with at least 2 of the following risk factors for PONV:
- Past history of PONV and/or motion sickness Habitual non-smoking status Female sex Expected to receive opioid analgesia post-operatively
- American Society of Anesthesiologists (ASA) risk score I-III -
Who cannot join
- Patients undergoing day case surgery
- Patients undergoing intra-thoracic, transplant or central nervous system surgery or any surgery where post-operative emesis may pose a significant danger to the patient
- Patients planned to receive only a local anaesthetic and/or regional neuraxial (intrathecal or epidural) block
- Patients who are scheduled to be transferred to the ICU after surgery;
- Patients who are expected to need a naso- or oral-gastric tube in situ after surgery is completed
- Patients who have a documented, clinically significant cardiac arrhythmia or congenital long QT syndrome（Male≥ 450 ms female≥ 460ms）.
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- Adequate hepatic and renal function, Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥ 2.5 x upper limit normal (ULN)，Bilirubin ≥ 1.5 x ULN，Creatinine ≥ 1.5x ULN
- Patients who have received Amisulpride active ingredient for any indication within the last 2 weeks
- Patients who are allergic to Amisulpride active ingredient or any of the excipients of Amisulpride
- Patients with a significant, ongoing history of vestibular disease or dizziness
- Intestinal obstruction
- Patients with a known prolactin-dependent tumour (e.g. pituitary gland prolactinoma or breast cancer) or phaeochromocytoma.
- Patients with pre-existing nausea or vomiting in the 24 hours before surgery
- Patients treated with regular anti-emetic therapy including corticosteroids
- Patients being treated with medications which could induce torsades de pointes, including Class Ia antiarrhythmic agents such as quinidine, disopyramide, procainamide; Class III antiarrhythmic agents such as amiodarone and sotalol; and other medications such as bepridil, cisapride, thioridazine, methadone, IV erythromycin, IV vincamine, halofantrine, pentamidine, sparfloxacin
- Patients being treated with levodopa or other dopamine drugs
- Patients who are pregnant or breast feeding.
- Participant who has a history of drug or alcohol abuse within 6 months before randomization
- Patients diagnosed with Parkinson's disease ，Patients with a history of epilepsy.
- Patients who have received anti-cancer chemotherapy in the previous 4 weeks of surgery
- Patients who have participated in other clinical research trials within 3 months before randomization
- Participant who may increase study-related risks or interfere with the interpretation of study results in the opinion of the investigator, who are considered unsuitable for enrollment by the investigator and/or the sponsor.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized, Double-blind, Placebo-controlled Phase III Study of Amisulpride for IV Injection as Prophylaxis Against Post-operative Nausea and Vomiting
A comparison of the efficacy of Amisulpride and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV.
- Conditions
- PONV
- Being tested
- Amisulpride, Amisulpride 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.
AmisulprideDrug
5mg/2ml
Amisulpride PlaceboDrug
2ml
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Amisulpride at 5mg was given by slow iv administration during1 to 2 min at induction of anesthesia Receives: Drug: Amisulpride |
| Placebo | Placebo comparator | Placebo was given by slow iv administration during1 to 2 min at induction of anesthesia Receives: Drug: Amisulpride Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint was the composite measure complete response
defined as no episodes of emesis (vomiting or retching) and no use of rescue medication in the first 24h after wound closure
Measured: 24 hours after the end of surgery
Secondary outcomes (5)
Incidence of no Nausea
Count of patients experiencing an episode of no nausea scored < 1 of 0-10 verbal response scale during the 24 hours period after the completion of surgery
Measured: 24 hours after end of surgery
Incidence of moderate and severe Nausea
Count of participants with nausea score > 4 on 0-10 verbal response scale
Measured: 24 hours after end of surgery
Incidence of Emesis (Vomiting/Retching)
An assessment of a participant experiencing an episode of emesis (vomiting/ retching) during the 24hours after the completion of the surgery
Measured: 24 hours after end of surgery
Use of Rescue Medication
Measured: 24 hours after end of surgery
Time to First Violation of Criteria for PONV
Criteria for PONV are any episode of emesis or use of rescue medication in the 24 hours after the end of surgery
Measured: 24 hours after 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 posted21 Apr 2023
- Study start29 Apr 2023 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PONVStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 516 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical (Hainan) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- yi feng, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822713
- Sponsor's protocol ID
- QLG2069-AMS-301
- Status last verified
- Apr 2023
- First submitted
- 27 Mar 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Phase III Study of Amisulpride for IV Injection as Prophylaxis Against Post-operative Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT05822713
- Acronym / sponsor ID
- QLG2069-AMS-301
- Conditions
- PONV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 516 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical (Hainan) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Apr 2023 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 Apr 2023 (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 comparison of the efficacy of Amisulpride and placebo in the prevention of PONV in patients at moderate-to-high risk of 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
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: AmisulprideAmisulpride at 5mg was given by slow iv administration during1 to 2 min at induction of anesthesia |
| Placebo | Placebo comparator | Drug: Amisulpride PlaceboPlacebo was given by slow iv administration during1 to 2 min at induction of anesthesia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent.
- Male or female patients ≥ 18 years of age and ≤75 years of age.
- 18<BMI≤30kg/m^2，And weigh more than 45kg
- Patients undergoing elective surgery(laparoscopic gynecological or abdominal surgery) under general anaesthesia requiring，and inhalation anesthesia is maintained for more than 1 hour, but patients who receive purely diagnostic surgery cannot be enrolled;
- Patients with at least 2 of the following risk factors for PONV:
Key exclusion criteria (22 listed)
- Patients undergoing day case surgery
- Patients undergoing intra-thoracic, transplant or central nervous system surgery or any surgery where post-operative emesis may pose a significant danger to the patient
- Patients planned to receive only a local anaesthetic and/or regional neuraxial (intrathecal or epidural) block
- Patients who are scheduled to be transferred to the ICU after surgery;
- Patients who are expected to need a naso- or oral-gastric tube in situ after surgery is completed
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 |
|---|---|---|
| Amisulpride5mg/2ml | Drug | Experimental |
| Amisulpride Placebo2ml | Drug | Placebo |
Primary outcome
The primary endpoint was the composite measure complete response
Time frame: 24 hours after the end of surgery
defined as no episodes of emesis (vomiting or retching) and no use of rescue medication in the first 24h after wound closure
5 secondary outcomes
Incidence of no Nausea
Time frame: 24 hours after end of surgery
Incidence of moderate and severe Nausea
Time frame: 24 hours after end of surgery
Incidence of Emesis (Vomiting/Retching)
Time frame: 24 hours after end of surgery
Use of Rescue Medication
Time frame: 24 hours after end of surgery
Time to First Violation of Criteria for PONV
Time frame: 24 hours after 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 21 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for PONV
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
Not yet recruiting
Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
Active, not recruiting
Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
Postoperative Nausea, Postoperative Vomiting
Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, Postoperative Nausea and Vomiting
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.
yi feng principal investigator
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amisulpride in people with PONV, run by Qilu Pharmaceutical (Hainan) 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 7 inclusion and 22 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 21 Apr 2023. 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 yi feng (010-88325988, yifeng65@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint was the composite measure complete response (time frame: 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 21 Apr 2023.