NCT02449291

Study of APD421 as PONV Treatment (no Prior Prophylaxis)

Randomised, Double-blind, Placebo-controlled Study of APD421 (Amisulpride for IV Injection) as Treatment of Established Post-operative Nausea and Vomiting, in Patients Who Have Had no Prior Prophylaxis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 568 (actual)
• Sponsor: Acacia Pharma Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Double-blind, randomised, parallel-group, placebo-controlled, adaptive, seamless, dose-selecting study to compare the efficacy of APD421 to placebo as treatment of established PONV, in patients who have not had prior PONV prophylaxis.

Conditions

• Postoperative Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	APD421
DRUG	Placebo

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-05-20
• Last updated: 2019-01-22
• Results posted: 2018-12-19

Locations

4 sites across 3 countries: United States, France, Germany