Trial intelligence / Profile preview

APD421 for Established PONV (Prior Prophylaxis)

NCT02646566Phase 3

Key facts

Status: Completed
Start: Mar 2016
Primary completion: Jan 2017
Countries: 3
Sponsor: Acacia Pharma Group Plc
Modality: Small Molecules

Drugs: amisulpride
Conditions: postoperative nausea and vomiting (PONV)

Overview

Phase 3, randomised, double-blind trial of amisulpride in postoperative nausea and vomiting (PONV) (3 arms), sponsored by Acacia Pharma Group Plc. Primary endpoint: Number of Participants With Complete Response (Success of Initial PONV Treatment). Started Mar 2016; status: completed.

Design

3 arms

Study design: RandomizedDouble-blind

APD421 standard
Single (standard) dose IV APD421
APD421 high
Single (high) dose IV APD421
Placebo
Single IV placebo

Who it enrols

Adult patients scheduled for elective surgery under general anaesthesia with moderate/high risk of PONV who have received prior prophylaxis and experienced a qualifying PONV episode within 24 hours post-op.

Endpoints

Primary

Number of Participants With Complete Response (Success of Initial PONV Treatment)0-24 hours

Secondary

Number of Participants With Complete Response 0-2 Hrs0-2 hours
Number of Participants With Complete Response 0-4 Hrs0-4 hours
Number of Participants With Complete Response 0-6 Hrs0-6 hours
Time to Treatment Failure0-24 hours
Number of Patients With Incidence of Emesis30 mins to 24 hours
Number of Patients Receiving Rescue Medication0-24 hours
Number of Patients With an Incidence of Significant Nausea30 mins to 24 hours
Number of Patients With an Incidence of Nausea30 mins to 24 hours

Results

Primary endpoints met

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