European Phase III Study of APD421 in PONV

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

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

Conditions
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PONV

Intervention / Treatment
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* Drug: APD421
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APD421<br>IV APD421 single dose | Drug: APD421<br> <br> |
| Placebo Comparator: Placebo<br>IV placebo single dose | Drug: Placebo<br> <br> |

What is the study measuring?
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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 |