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NCT05546359 · ClinicalTrials.gov registry record · Phase 2
Study of Intravenous Amisulpride for Prophylaxis of Post-operative Nausea and Vomiting (PONV) in Pediatric Patients
A Phase 2 study of Nausea and Vomiting, Postoperative, sponsored by Acacia Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 453
- Enrollment target
- 14
- Study locations
NCT05546359: Completed Phase 2 study of Nausea and Vomiting, Postoperative, sponsored by Acacia Pharma.
NCT05546359 is a Phase 2 study of Nausea and Vomiting, Postoperative that has completed, run by Acacia Pharma. The registered enrollment target is 453 participants, above the 177-participant average among 5 other Nausea and Vomiting, Postoperative trials with a reported enrollment target (156% higher). The trial reports 14 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05546359, a Phase 2 study of Nausea and Vomiting, Postoperative, has completed, sponsored by Acacia Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 453 participants
- Enrollment target
- 14
- Study locations
Study Summary
Randomized, double-blind, pediatric trial of amisulpride for prophylaxis of post operative nausea and vomiting
Primary Outcome
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 453 participants |
| Start Date | 2024-01-18 |
| Est. Completion | 2025-06-03 |
| Phase | Phase 2 |
What the finished NCT05546359 record still lists
NCT05546359 is an interventional study that assigns participants to a tested intervention. The registered 453 participants enrollment target is mid-sized for trials with a published cap, above the 177-participant average among 5 other Nausea and Vomiting, Postoperative trials with a reported enrollment target (156% higher).
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.
NCT05546359 lists 14 locations in 10 states (Other, Pennsylvania, Hesse).
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.
What interventions are being tested in trial NCT05546359?
The interventions under investigation include: Dexamethasone (DRUG), Amisulpride Injection (DRUG).
Who is sponsoring clinical trial NCT05546359?
This trial is sponsored by Acacia Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.
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.
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