Study of Intravenous Amisulpride for Prophylaxis of Post-operative Nausea and Vomiting (PONV) in Pediatric Patients

Completed · Phase 2/Phase 3

Conditions studied: Nausea and Vomiting, Postoperative

In brief

Randomized, double-blind, pediatric trial of amisulpride for prophylaxis of post operative nausea and vomiting

Key facts

Study ID

NCT05546359

Run by

Acacia Pharma Ltd

People needed

453

Starts

2024-01-18

Expected to finish

2025-06-03

Last updated by the study team

2025-06-25

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• 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

Where it is running

• Helen Keller Hospital — Sheffield, Alabama, United States
• Emory Healthcare - Emory University Hospital — Atlanta, Georgia, United States
• University of Minnesota Masonic Children's Hospital — Minneapolis, Minnesota, United States
• The Children's Hospital of Philadelphia (CHOP) — Philadelphia, Pennsylvania, United States
• UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• The Hospital for Sick Children — Toronto, Ontario, Canada
• McGill University Health Centre - The Montréal Children's Hospital — Montreal, Quebec, Canada
• HCL - Hôpital Mère Enfant — Bron, France
• CHU Strasbourg - Hopital Hautepierre — Strasbourg, France
• Universitätsklinikum Würzburg — Würzburg, Bavaria, Germany
• Ambulantes Operieren Marburg — Marburg, Hesse, Germany
• Universitaetsklinikum Giessen und Marburg GmbH — Marburg, Hesse, Germany
• Universitaetsklinikum Bonn - Klinik für Anaesthesiologie & Operative Intensivmedizin — Bonn, North Rhine-Westphalia, Germany
• Helios Klinikum Aue — Aue, Germany

Full record on ClinicalTrials.gov

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