Study of APD421 as PONV Treatment (no Prior Prophylaxis)

Phase 3 Completed 568 enrolled Acacia Pharma Ltd

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2015-09
Primary completion: 2016-07
Completion: 2016-07

Outcome

Met primary endpoint

registry analysis (superiority test); APD421 10mg IV vs Placebo; p = 0.016; Chi-squared; note: One-sided p-value. NCT02449291 ↗

paper Complete response occurred in 39 of 181 patients (21.5%) in the placebo group compared to 60 of 191 patients (31.4%; P = .016) PMID 31094774 ↗

Publications

Candiotti KA, Kranke P, Bergese SD, Melson TI, Motsch J, Siddiqui N, Chung F, Rodriguez Y, Minkowitz HS, Ayad SS, Diemunsch P, Fox G. Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Amisulpride as Treatment of Established Postoperative Nausea and Vomiting in Patients Who Have Had No Prior Prophylaxis. Anesth Analg. 2019 Jun;128(6):1098-1105. doi: 10.1213/ANE.0000000000003733.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amisulpride	Small molecule	5 mg	Intravenous
Subject	Amisulpride	Small molecule	10 mg	Intravenous

Indications

No indication recorded.