Nausea and Vomiting, PostoperativePhase 2/3NCT05546359
Study of Intravenous Amisulpride for Prophylaxis of Post-operative Nausea and Vomiting (PONV) in Pediatric Patients
A Phase 2/3 study testing Amisulpride Injection and Dexamethasone in people with Nausea and Vomiting, Postoperative, run by Acacia Pharma Ltd at 14 sites in 4 countries.
Trial summary
Randomized, double-blind, pediatric trial of amisulpride for prophylaxis of post operative nausea and vomiting Read more about this study
- Who is it for?
- Ages 2 months to 17 years
- Conditions the study is for
- Nausea and Vomiting, Postoperative
- What is being tested?
- Amisulpride Injection and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 453 participants
- Where
- 14 sitesin 4 countries
- Study dates
- 18 Jan 2024to 3 Jun 2025
- Phase
- Phase 2/3
- 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 2 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female patients aged from full-term birth to 17 years of age
- Signed informed consent form and/or assent and willingness of patient and parents to participate in the trial
- Patients undergoing non-emergency surgery, preferentially eye surgery, adenotonsillectomy or otoplasty, under general anesthesia (other than total intravenous anesthesia with propofol) expected to last at least 30 minutes from induction of anesthesia to removal of Endotracheal tube (ETT) or Laryngeal mask airway (LMA)
- American Society of Anesthesiologists (ASA) risk score I-III
- For females of child-bearing potential: ability and willingness to use a highly effective form of contraception (as defined in ICH M3 guidance, e.g., true (not periodic) abstinence from sexual intercourse, surgical sterilization (of subject or partner), combined oral contraceptive pill, or any other method or combination of methods with a failure rate generally considered to be <1% per year) between the date of screening and at least 48 hours after administration of study drug.
Who cannot join
- Patients scheduled to undergo transplant or Central Nervous System (CNS) surgery
- Patients scheduled to receive only a local anesthetic and/or regional neuraxial (intrathecal or epidural) block (without general anesthesia) or to receive general anesthesia involving total intravenous anesthesia (TIVA) with propofol
- Patients who, in the opinion of the Investigator, are expected to remain ventilated for a significant period after surgery
- Patients who are expected to need a naso- or orogastric tube in situ after surgery is completed
- Patients who are expected to receive systemic pre/peri-operative corticosteroid therapy other than as anti-emetic prophylaxis
- Patients receiving amisulpride for any indication within the 2 weeks prior to randomization
Show all 17Show fewer
- Patients known to be allergic to amisulpride or any of the excipients of amisulpride drug product; or to dexamethasone or ondansetron
- Patients with a significant ongoing history of vestibular disease or dizziness
- Patients being treated with regular anti-emetic therapy (dosed at least three times per week), which is still ongoing less than 1 week prior to screening
- Patients being treated with levodopa, or any other dopamine D2-agonist
- Patients who are pregnant or breast feeding
- Patients with congenital long QT interval (QT) syndrome
- Patients with a tumor of the anterior pituitary
- Patients who have received emetogenic anti-cancer chemotherapy in the previous 4 weeks
- Any other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study
- Patients who have previously participated in this study or who have participated in another interventional clinical study involving pharmacological therapy within the previous 28 days (or longer exclusion period, if required by national or local regulations)
- Where local laws/regulations require: patients under legal protection
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
United States5 sites
Emory Healthcare - Emory University Hospital
Atlanta, Georgia, 30322
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, 55455
The Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, 19104
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Helen Keller Hospital
Sheffield, Alabama, 35660
Germany5 sites
Helios Klinikum Aue
Aue, 08280
Universitaetsklinikum Bonn - Klinik für Anaesthesiologie & Operative Intensivmedizin
Bonn, North Rhine-Westphalia, 53127
Ambulantes Operieren Marburg
Marburg, Hesse, 35039
Universitaetsklinikum Giessen und Marburg GmbH
Marburg, Hesse, 35043
Universitätsklinikum Würzburg
Würzburg, Bavaria, 97080
Canada2 sites
McGill University Health Centre - The Montréal Children's Hospital
Montreal, Quebec, H4A 3J1
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
France2 sites
HCL - Hôpital Mère Enfant
Bron, 69677
CHU Strasbourg - Hopital Hautepierre
Strasbourg, 67200
About this study
Official title: Randomized, Double-blind, Phase 2/3 Study of IV Amisulpride as Prevention of Post-operative Nausea and Vomiting in Pediatric Patients
Randomized, double-blind, pediatric trial of amisulpride for prophylaxis of post operative nausea and vomiting
Read the detailed description
Randomized, double-blind, Phase 2/3 study of IV amisulpride as prevention of post-operative nausea and vomiting in pediatric patients
- Conditions
- Nausea and Vomiting, Postoperative
- Being tested
- Amisulpride Injection, Dexamethasone
- 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.
Amisulpride InjectionDrug
Also called Barhemsys
Dose finding treatment for continuation to phase 3
DexamethasoneDrug
Also called Decadron
Standard of care treatment
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 - Group 1: IV amisulpride 0.035 mg/kg + IV dexamethasone | Experimental | Stage 1 - Group 1: IV amisulpride 0.035 mg/kg + IV dexamethasone Receives: Drug: Amisulpride Injection; Drug: Dexamethasone |
| Stage 1 - Group 2: IV amisulpride 0.07 mg/kg + IV dexamethasone | Experimental | Stage 1 - Group 2: IV amisulpride 0.07 mg/kg + IV dexamethasone Receives: Drug: Amisulpride Injection; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Complete Response
Defined as no vomiting/retching (absence of PONV) and no use of anti-emetic rescue medication, during the first 24 hours after completion of surgery. Subjects will be questioned and assessed.
Measured: 1 Day
Secondary outcomes (10)
Occurrence of post-operative vomiting/retching
Subjects considered able to understand and provide a meaningful response should be asked if they have nausea ("feel sick" or other equivalent words) at the following times after completion of surgery (wound closure), unless an episode of PONV or discharge of the subject from the site has already occurred prior to the time point: 1 hour, 2 hours, 6 hours and 24 hours or when they first vomit, retch or receive rescue medication. In subjects aged ≥ 6 years, at the above time points and for any spontaneously reported nausea episode, nausea severity should be scored using the validated 6-point Baxter Retching Faces (BARF) scale.
Measured: 1 Day
Use of rescue medication
Document use of rescue medication.
Measured: 1 Day
Occurrence and severity of post-operative nausea
An episode of nausea should be recorded any time that a subject spontaneously complains of nausea (including a request for rescue medication due to nausea). Subjects considered able to understand and provide a meaningful response should be asked if they have nausea ("feel sick" or other equivalent words) at the following times after completion of surgery (wound closure), unless an episode of PONV or discharge of the subject from the site has already occurred prior to the time point: 1 hour, 2 hours, 6 hours and 24 hours or when they first vomit, retch or receive rescue medication. In subjects aged ≥ 6 years, at the above time points and for any spontaneously reported nausea episode, nausea severity should be scored using the validated 6-point Baxter Retching Faces (BARF) scale.
Measured: 1 Day
Time to emergence of PONV
Observe for, question and document emergence of vomiting/retching and nausea. In subjects aged ≥ 6 years, at specified time points and for any spontaneously reported nausea episode, nausea severity should be scored using the validated 6-point Baxter Retching Faces (BARF) scale.
Measured: 1 Day
Time to emergence of vomiting/retching, significant nausea, and rescue medication, individually
Observe for emergence of vomiting/retching, determine significance of nausea, and note rescue medication, individually.
Measured: 1 Day
Different variables during different time ranges after the end of surgery (0-2 h, 2-6 h and 6-24 h)
Subjects considered able to understand and provide a meaningful response should be asked if they have nausea ("feel sick" or other equivalent words) at the following times after completion of surgery (wound closure), unless an episode of PONV or discharge of the subject from the site has already occurred prior to the time point: 1 hour, 2 hours, 6 hours and 24 hours or when they first vomit, retch or receive rescue medication. In subjects aged ≥ 6 years, at the above time points and for any spontaneously reported nausea episode, nausea severity should be scored using the validated 6-point Baxter Retching Faces (BARF) scale.
Measured: 1 Day
The above variables in the sub-groups of patients who did and did not receive opioid analgesia
Concomitant medications will be reviewed.
Measured: 1 Day
Safety: The nature and frequency of adverse events and laboratory and electrocardiography (ECG) abnormalities
Adverse events, laboratory and ECG abnormalities will be noted. Blood samples should be drawn at screening (unless recent pre-existing results are available) and again post-operatively, as soon as practically possible after the patient's entry to the post-anesthesia care unit, recovery room or equivalent, and in any event within 1 hour after the end of surgery. Twelve-lead ECGs will be collected at screening. An ECG already taken as part of medical care within the period of 2 weeks prior to screening may be used to determine eligibility and to provide baseline ECG data.
In the peri-/post-operative period, continuous Holter monitoring of the ECG will be performed, from at least 10 minutes prior until at least 2 hours after the start of administration of amisulpride study medication.
Measured: 7 Days
Key pharmacokinetics parameter - Peak Plasma Concentration
Plasma samples will be drawn as required at specified timepoints to determine the PK profile of peak plasma concentration of amisulpride in subjects.
Measured: 1 Day
Key pharmacokinetics parameter - Total Exposure
Plasma samples will be drawn as required at specified timepoints to determine the PK profile of total exposure of amisulpride in subjects.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start18 Jan 2024
- Primary completion3 Jun 2025
- Study completion3 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea and Vomiting, PostoperativeStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 453 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acacia Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amicus CD LLC, Premier Research
- Responsible party
- Sponsor
- Investigators
- Kumar Belani, MD, Principal investigator, University of Minnesota Masonic Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546359
- Sponsor's protocol ID
- DP10027
- Status last verified
- Jun 2025
- First submitted
- 12 Sep 2022
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Phase 2/3 Study of IV Amisulpride as Prevention of Post-operative Nausea and Vomiting in Pediatric Patients
- ClinicalTrials.gov ID
- NCT05546359
- Acronym / sponsor ID
- DP10027
- Conditions
- Nausea and Vomiting, Postoperative
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 453 participants (actual)
- Lead sponsor
- Acacia Pharma LtdIndustry (pharma, biotech, devices)
- Collaborators
- Amicus CD LLC, Premier Research
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 19 Sep 2022 (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.
Randomized, double-blind, pediatric trial of amisulpride for prophylaxis of post operative nausea and vomiting
Detailed description
Randomized, double-blind, Phase 2/3 study of IV amisulpride as prevention of post-operative nausea and vomiting in pediatric patients
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage 1 - Group 1: IV amisulpride 0.035 mg/kg + IV dexamethasone | Experimental | Drug: Amisulpride Injection, Drug: DexamethasoneStage 1 - Group 1: IV amisulpride 0.035 mg/kg + IV dexamethasone |
| Stage 1 - Group 2: IV amisulpride 0.07 mg/kg + IV dexamethasone | Experimental | Drug: Amisulpride Injection, Drug: DexamethasoneStage 1 - Group 2: IV amisulpride 0.07 mg/kg + IV dexamethasone |
Who may qualify
- Ages
- 2 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male or female patients aged from full-term birth to 17 years of age
- Signed informed consent form and/or assent and willingness of patient and parents to participate in the trial
- Patients undergoing non-emergency surgery, preferentially eye surgery, adenotonsillectomy or otoplasty, under general anesthesia (other than total intravenous anesthesia with propofol) expected to last at least 30 minutes from induction of anesthesia to removal of Endotracheal tube (ETT) or Laryngeal mask airway (LMA)
- American Society of Anesthesiologists (ASA) risk score I-III
- For females of child-bearing potential: ability and willingness to use a highly effective form of contraception (as defined in ICH M3 guidance, e.g., true (not periodic) abstinence from sexual intercourse, surgical sterilization (of subject or partner), combined oral contraceptive pill, or any other method or combination of methods with a failure rate generally considered to be <1% per year) between the date of screening and at least 48 hours after administration of study drug.
Key exclusion criteria (17 listed)
- Patients scheduled to undergo transplant or Central Nervous System (CNS) surgery
- Patients scheduled to receive only a local anesthetic and/or regional neuraxial (intrathecal or epidural) block (without general anesthesia) or to receive general anesthesia involving total intravenous anesthesia (TIVA) with propofol
- Patients who, in the opinion of the Investigator, are expected to remain ventilated for a significant period after surgery
- Patients who are expected to need a naso- or orogastric tube in situ after surgery is completed
- Patients who are expected to receive systemic pre/peri-operative corticosteroid therapy other than as anti-emetic prophylaxis
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 |
|---|---|---|
| Amisulpride InjectionAlso: BarhemsysDose finding treatment for continuation to phase 3 | Drug | Stage 1 - Group 1: IV amisulpride 0.035 mg/kg + IV dexamethasone, Stage 1 - Group 2: IV amisulpride 0.07 mg/kg + IV dexamethasone |
| DexamethasoneAlso: DecadronStandard of care treatment | Drug | Stage 1 - Group 1: IV amisulpride 0.035 mg/kg + IV dexamethasone, Stage 1 - Group 2: IV amisulpride 0.07 mg/kg + IV dexamethasone |
Primary outcome
Evaluate Complete Response
Time frame: 1 Day
Defined as no vomiting/retching (absence of PONV) and no use of anti-emetic rescue medication, during the first 24 hours after completion of surgery. Subjects will be questioned and assessed.
10 secondary outcomes
Occurrence of post-operative vomiting/retching
Time frame: 1 Day
Use of rescue medication
Time frame: 1 Day
Occurrence and severity of post-operative nausea
Time frame: 1 Day
Time to emergence of PONV
Time frame: 1 Day
Time to emergence of vomiting/retching, significant nausea, and rescue medication, individually
Time frame: 1 Day
Different variables during different time ranges after the end of surgery (0-2 h, 2-6 h and 6-24 h)
Time frame: 1 Day
The above variables in the sub-groups of patients who did and did not receive opioid analgesia
Time frame: 1 Day
Safety: The nature and frequency of adverse events and laboratory and electrocardiography (ECG) abnormalities
Time frame: 7 Days
Key pharmacokinetics parameter - Peak Plasma Concentration
Time frame: 1 Day
Key pharmacokinetics parameter - Total Exposure
Time frame: 1 Day
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 25 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Nausea and Vomiting, Postoperative
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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.
Kumar Belani, MD principal investigator
University of Minnesota Masonic Children's Hospital
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Amisulpride Injection and Dexamethasone in people with Nausea and Vomiting, Postoperative, run by Acacia Pharma Ltd at 14 sites in 4 countries.
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 5 inclusion and 17 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 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Germany, Canada, France. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Evaluate Complete Response (time frame: 1 Day). 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 25 Jun 2025.