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COMPLETED Phase 2

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

NCT05546359 · View on ClinicalTrials.gov ↗

Study Summary

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

Interventions

  • DRUG Dexamethasone
  • DRUG Amisulpride Injection

Study Locations (14)

Other

  • HCL - Hôpital Mère Enfant — Bron
  • CHU Strasbourg - Hopital Hautepierre — Strasbourg
  • Helios Klinikum Aue — Aue

Pennsylvania

  • The Children's Hospital of Philadelphia (CHOP) — Philadelphia
  • UPMC Children's Hospital of Pittsburgh — Pittsburgh

Hesse

  • Ambulantes Operieren Marburg — Marburg
  • Universitaetsklinikum Giessen und Marburg GmbH — Marburg

Alabama

  • Helen Keller Hospital — Sheffield

Georgia

  • Emory Healthcare - Emory University Hospital — Atlanta

Minnesota

  • University of Minnesota Masonic Children's Hospital — Minneapolis

Ontario

  • The Hospital for Sick Children — Toronto

Quebec

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

Trial Details

FieldValue
Enrollment Target 453 participants
Start Date 2024-01-18
Est. Completion 2025-06-03
Phase Phase 2

Sponsor

Acacia Pharma

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05546359

The ClinicalTrials.gov registry entry for NCT05546359 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 453 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Acacia Pharma, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Nausea and Vomiting, Postoperative appearing as the primary indexed condition, and to 2 interventions — of which Dexamethasone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05546359 reports 14 study locations spanning 10 distinct geographic areas — top geographies include Other, Pennsylvania, Hesse. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05546359 about?

NCT05546359 is a clinical study titled "Study of Intravenous Amisulpride for Prophylaxis of Post-operative Nausea and Vomiting (PONV) in Pediatric Patients". Randomized, double-blind, pediatric trial of amisulpride for prophylaxis of post operative nausea and vomiting

What is the current status of trial NCT05546359?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 453 participants. The study started on 2024-01-18. Estimated completion is 2025-06-03.

What conditions does trial NCT05546359 study?

This clinical trial studies the following conditions: Nausea and Vomiting, Postoperative. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05546359?

The interventions under investigation include: Dexamethasone (DRUG), Amisulpride Injection (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05546359?

This trial is sponsored by Acacia Pharma, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05546359 being conducted?

This trial has 14 study locations across Alabama, Georgia, Minnesota, Pennsylvania, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial