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

NCT ID: NCT05546359

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 453 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-18
• Study Completion Date: 2025-06-03

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

Conditions

Nausea and Vomiting, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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

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

Group Type: EXPERIMENTAL

Amisulpride Injection

Intervention Type: DRUG

Dose finding treatment for continuation to phase 3

Dexamethasone

Intervention Type: DRUG

Standard of care treatment

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

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

Group Type: EXPERIMENTAL

Amisulpride Injection

Intervention Type: DRUG

Dose finding treatment for continuation to phase 3

Dexamethasone

Intervention Type: DRUG

Standard of care treatment

Interventions

Amisulpride Injection

Dose finding treatment for continuation to phase 3

Intervention Type: DRUG

Dexamethasone

Standard of care treatment

Intervention Type: DRUG

Other Intervention Names

Barhemsys; Decadron

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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amicus CD LLC

UNKNOWN

Sponsor Role: collaborator

Premier Research

OTHER

Sponsor Role: collaborator

Acacia Pharma Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kumar Belani, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota Masonic Children's Hospital

Locations

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

Countries

United States; Canada; France; Germany

Other Identifiers

DP10027

Identifier Type: -

Identifier Source: org_study_id