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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

453

Participants

Timeline

Start Date

January 18, 2024

Primary Completion Date

June 3, 2025

Study Completion Date

June 3, 2025

Conditions
Nausea and Vomiting, Postoperative
Interventions
DRUG

Amisulpride Injection

Dose finding treatment for continuation to phase 3

DRUG

Dexamethasone

Standard of care treatment

Trial Locations (14)

15224

UPMC Children's Hospital of Pittsburgh, Pittsburgh

19104

The Children's Hospital of Philadelphia (CHOP), Philadelphia

30322

Emory Healthcare - Emory University Hospital, Atlanta

35039

Ambulantes Operieren Marburg, Marburg

35043

Universitaetsklinikum Giessen und Marburg GmbH, Marburg

35660

Helen Keller Hospital, Sheffield

53127

Universitaetsklinikum Bonn - Klinik für Anaesthesiologie & Operative Intensivmedizin, Bonn

55455

University of Minnesota Masonic Children's Hospital, Minneapolis

67200

CHU Strasbourg - Hopital Hautepierre, Strasbourg

69677

HCL - Hôpital Mère Enfant, Bron

97080

Universitätsklinikum Würzburg, Würzburg

M5G 1X8

The Hospital for Sick Children, Toronto

H4A 3J1

McGill University Health Centre - The Montréal Children's Hospital, Montreal

08280

Helios Klinikum Aue, Aue

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Amicus CD LLC

UNKNOWN

collaborator

Premier Research

OTHER

lead

Acacia Pharma Ltd

INDUSTRY