NCT05546359

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

Randomized, Double-blind, Phase 2/3 Study of IV Amisulpride as Prevention of Post-operative Nausea and Vomiting in Pediatric Patients

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 453 (actual)
• Sponsor: Acacia Pharma Ltd · Industry
• Sex: All
• Age: 2 Months – 17 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Amisulpride Injection	Dose finding treatment for continuation to phase 3
DRUG	Dexamethasone	Standard of care treatment

Timeline

• Start date: 2024-01-18
• Primary completion: 2025-06-03
• Completion: 2025-06-03
• First posted: 2022-09-19
• Last updated: 2025-06-25

Locations

14 sites across 4 countries: United States, Canada, France, Germany

Regulatory

• FDA-regulated drug study