Trial intelligence / Profile preview

APD421 for PONV prophylaxis

NCT01991860Phase 3

Key facts

Status: Completed
Start: Aug 2013
Primary completion: Jan 2014
Countries: 1
Sponsor: Acacia Pharma Group Plc
Modality: Small Molecules

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

Overview

Phase 3, randomised, double-blind trial in postoperative nausea and vomiting (PONV) comparing APD421 with Placebo (2 arms). Primary endpoint: Number of Participants With Complete Response at 24 hours. Started Aug 2013; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

APD421
Amisulpride 5mg IV single dose
Placebo
Matching placebo IV single dose

Who it enrols

Adult patients undergoing elective surgery under general anesthesia expected to last >1 hour and requiring overnight stay, with moderate-to-high risk of PONV (>=2 Apfel risk factors).

Endpoints

Primary

Number of Participants With Complete Response24 hours

Secondary

Number of Participants With no Nausea24 hours
Number of Participants With no Emesis24 hours
Number of Participants With no Use of Rescue Medication24 hours
Number of Participants With Total Response24 hours

Results

Primary endpoints met

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