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

NCT05546359 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 453

Last updated 2025-06-25

No results posted yet for this study

Summary

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

Conditions

  • Nausea and Vomiting, Postoperative

Interventions

DRUG

Amisulpride Injection

Dose finding treatment for continuation to phase 3

DRUG

Dexamethasone

Standard of care treatment

Sponsors & Collaborators

  • Amicus CD LLC

    collaborator UNKNOWN

  • Premier Research

    collaborator OTHER

  • Acacia Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Kumar Belani, MD · University of Minnesota Masonic Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-18
Primary Completion
2025-06-03
Completion
2025-06-03
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05546359 on ClinicalTrials.gov