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

NCT05546359 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: DP10027
• Study Type: interventional
• Target: 453
• Locations: 4 countries
• Sites: 14

Brief Summary

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

Conditions

Nausea and Vomiting, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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.

  1 Day

Secondary Outcomes (10)

• Occurrence of post-operative vomiting/retching

  1 Day

• Use of rescue medication

  1 Day

• Occurrence and severity of post-operative nausea

  1 Day

• Time to emergence of PONV

  1 Day

• Time to emergence of vomiting/retching, significant nausea, and rescue medication, individually

  1 Day

Study Arms (2)

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

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

Drug: Amisulpride Injection; Drug: Dexamethasone

Interventions

Amisulpride Injection DRUG

Dose finding treatment for continuation to phase 3

Also known as: Barhemsys

Stage 1 - Group 1: IV amisulpride 0.035 mg/kg + IV dexamethasone; Stage 1 - Group 2: IV amisulpride 0.07 mg/kg + IV dexamethasone

Dexamethasone DRUG

Standard of care treatment

Also known as: Decadron

Stage 1 - Group 1: IV amisulpride 0.035 mg/kg + IV dexamethasone; Stage 1 - Group 2: IV amisulpride 0.07 mg/kg + IV dexamethasone

Eligibility Criteria

• Age: 2 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Acacia Pharma Ltd: lead
• Amicus CD LLC: collaborator
• Premier Research: collaborator

Study Sites (14)

Helen Keller Hospital

Sheffield, Alabama, 35660, United States

Location

Emory Healthcare - Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota, 55455, United States

Location

The Children's Hospital of Philadelphia (CHOP)

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

McGill University Health Centre - The Montréal Children's Hospital

Montreal, Quebec, H4A 3J1, Canada

Location

HCL - Hôpital Mère Enfant

Bron, 69677, France

Location

CHU Strasbourg - Hopital Hautepierre

Strasbourg, 67200, France

Location

Universitätsklinikum Würzburg

Würzburg, Bavaria, 97080, Germany

Location

Ambulantes Operieren Marburg

Marburg, Hesse, 35039, Germany

Location

Universitaetsklinikum Giessen und Marburg GmbH

Marburg, Hesse, 35043, Germany

Location

Universitaetsklinikum Bonn - Klinik für Anaesthesiologie & Operative Intensivmedizin

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Helios Klinikum Aue

Aue, 08280, Germany

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Amisulpride; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Kumar Belani, MD

  University of Minnesota Masonic Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 19, 2022
• Study Start: January 18, 2024
• Primary Completion: June 3, 2025
• Study Completion: June 3, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (5); FR (2); DE (5)