drugset / Trial / NCT01991821

European Phase III Study of APD421 in PONV

NCT01991821 ↗

Phase 3 Completed 368 enrolled Acacia Pharma Ltd
RandomizedParallel-groupQuadruple-blindPrevention

Summary

A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV.

Timeline

Start
2013-07
Primary completion
2014-01
Completion
2014-01

Outcome

Missed primary endpoint

registry analysis (superiority test); APD421 vs Placebo; p = 0.093; Chi-squared, Corrected NCT01991821 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Amisulpride Small molecule — Intravenous

Indications

No indication recorded.