Clinical trial NCT05546359: Study of Intravenous Amisulpride for Prophylaxis of Post-operative Nausea and Vomiting (PONV) in Pediatric Patients
Official title: Randomized, Double-blind, Phase 2/3 Study of IV Amisulpride as Prevention of Post-operative Nausea and Vomiting in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Nausea and Vomiting, Postoperative
Lead sponsor: Acacia Pharma Ltd
Sponsor class: INDUSTRY
Collaborators: name: Amicus CD LLC
name: Premier Research Group plc
First posted: 2022-09-19
Enrollment: 410
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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

Eligibility criteria: Inclusion Criteria:

1. Male or female patients aged from full-term birth to 17 years of age
2. Signed informed consent form and/or assent and willingness of patient and parents to participate in the trial
3. 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)
4. American Society of Anesthesiologists (ASA) risk score I-III
5. 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.

Exclusion Criteria:

1. Patients scheduled to undergo transplant or Central Nervous System (CNS) surgery
2. 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
3. Patients who, in the opinion of the Investigator, are expected to remain ventilated for a significant period after surgery
4. Patients who are expected to need a naso- or orogastric tube in situ after surgery is completed
5. Patients who are expected to receive systemic pre/peri-operative corticosteroid therapy other than as anti-emetic prophylaxis
6. Patients receiving amisulpride for any indication within the 2 weeks prior to randomization
7. Patients known to be allergic to amisulpride or any of the excipients of amisulpride drug product; or to dexamethasone or ondansetron
8. Patients with a significant ongoing history of vestibular disease or dizziness
9. 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
10. Patients being treated with levodopa, or any other dopamine D2-agonist
11. Patients who are pregnant or breast feeding
12. Patients with congenital long QT interval (QT) syndrome
13. Patients with a tumor of the anterior pituitary
14. Patients who have received emetogenic anti-cancer chemotherapy in the previous 4 weeks
15. Any other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study
16. 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)
17. Where local laws/regulations require: patients under legal protection

Primary outcomes:
measure: Evaluate Complete Response
timeFrame: 1 Day
Secondary outcomes:
measure: Occurrence of post-operative vomiting/retching
timeFrame: 1 Day
measure: Use of rescue medication
timeFrame: 1 Day
measure: Occurrence and severity of post-operative nausea
timeFrame: 1 Day
measure: Time to emergence of PONV
timeFrame: 1 Day
measure: Time to emergence of vomiting/retching, significant nausea, and rescue medication, individually
timeFrame: 1 Day
measure: Different variables during different time ranges after the end of surgery (0-2 h, 2-6 h and 6-24 h)
timeFrame: 1 Day
measure: The above variables in the sub-groups of patients who did and did not receive opioid analgesia
timeFrame: 1 Day
measure: Safety: The nature and frequency of adverse events and laboratory and electrocardiography (ECG) abnormalities
timeFrame: 7 Days
measure: Key pharmacokinetics parameter - Peak Plasma Concentration
timeFrame: 1 Day
measure: Key pharmacokinetics parameter - Total Exposure
timeFrame: 1 Day
Other outcomes:
Locations:
city: Sheffield
country: United States
facility: Helen Keller Hospital
state: Alabama
city: Atlanta
country: United States
facility: Emory Healthcare - Emory University Hospital
state: Georgia
city: Minneapolis
country: United States
facility: University of Minnesota Masonic Children's Hospital
state: Minnesota
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia (CHOP)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Montréal
country: Canada
facility: McGill University Health Centre - The Montréal Children's Hospital
state: Quebec
city: Bron
country: France
facility: HCL - Hôpital Mère Enfant
city: Strasbourg
country: France
facility: CHU Strasbourg - Hopital Hautepierre
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
state: Bayern
city: Marburg
country: Germany
facility: Ambulantes Operieren Marburg
state: Hessen
city: Marburg
country: Germany
facility: Universitaetsklinikum Giessen und Marburg GmbH
state: Hessen
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn - Klinik für Anaesthesiologie & Operative Intensivmedizin
state: Nordrhein-Westfalen
city: Aue
country: Germany
facility: Helios Klinikum Aue
Study officials:
affiliation: University of Minnesota Masonic Children's Hospital
name: Kumar Belani, MD
role: PRINCIPAL_INVESTIGATOR
References: