European Phase III Study of APD421 in PONV

Randomised, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Prophylaxis Against Post-operative Nausea and Vomiting

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

Study Overview

• Status: Completed
• Conditions: PONV
• Intervention / Treatment: Drug: Placebo; Drug: APD421

• Study Type: Interventional
• Enrollment (Actual): 368
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Strasbourg, France
    • CHU de Hautepierre
• Germany
  • Würzburg, Germany
    • University Hospitals of Würzburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female patients ≥ 18 years of age
• Patients undergoing elective surgery (open or laparoscopic technique) under general anaesthesia, expected to last at least one hour from induction of anaesthesia to wound closure and expected to require at least one overnight stay in hospital

Exclusion Criteria:

• Patients scheduled for outpatient/day case surgery
• Patients scheduled to undergo intra-thoracic, transplant or central nervous system surgery
• Patients scheduled to receive only a local anaesthetic/regional neuraxial (intrathecal or epidural) block
• Patients who are expected to remain ventilated for a period after surgery
• Patients who are expected to need a naso- or orogastric tube in situ after surgery is completed

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: APD421; IV APD421 single dose	Drug: APD421
Placebo Comparator: Placebo; IV placebo single dose	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response (no Emesis, Significant Nausea or Rescue Medication)	The primary efficacy analysis was a comparison of the incidence of Complete Response (absence of PONV1) in the 0-24-hour period after surgery, between the active treatment group and the placebo group using Pearson square test with Yates's continuity correction at a two-sided significance level of 5%.	24 hours after end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response (no Emesis or Rescue Medication)		24 hrs after end of surgery
Total Response (no Emesis, Nausea or Rescue Medication)		24 hrs after end of surgery
Incidence of Emesis (Vomiting/Retching)	An assessment of a participant experiencing an episode of emesis (vomiting/ retching) or received anti-emetic rescue medication during the 24hours after the completion of the surgery	24 hours after end of surgeryry
Incidence of Nausea	Count of patients experiencing an episode of nausea scored ≥ 1 of 0-10 verbal response scale during the 24 hours period after the completion of surgery	24 hours after end of surgery
Incidence of Significant Nausea	Count of participants with nausea score ≥ 4 on 0-10 verbal response scale	24 hours after end of surgery
Use of Rescue Medication		24 hours after end of surgery

Collaborators and Investigators

• Sponsor: Acacia Pharma Ltd
• Investigators: Principal Investigator: Pierre Diemunsch, MD, Hôpital de HAUTEPIERRE

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: November 11, 2013
• First Submitted That Met QC Criteria: November 18, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 9, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: DP10014