Phase IIIb Study of APD421 in Combination as PONV Prophylaxis

Study Overview
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Brief Summary
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A comparison of the efficacy of APD421 and placebo when combined with a standard anti-emetic in the prevention of PONV in patients at high risk of Post-operative Nausea and Vomiting (PONV).

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

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 Patients with at least 3 Apfel risk factors for PONV Exclusion Criteria: Patients scheduled to undergo transplant 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 + standard anti-emetic<br>Single dose of IV APD421 | Drug: APD421<br> <br> |
| Placebo Comparator: Placebo + standard anti-emetic<br>Single dose of IV placebo | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Complete Response | Complete response defined as no emesis and no use of rescue medication in the 24 hour period after end of surgery (defined as wound closure) | 24 hours after the end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Emesis | Emesis is defined as vomiting (production of even the smallest amount of stomach contents) or retching (muscular movements of vomiting but without expulsion of stomach contents, usually because of an empty stomach) | 24 hours after the end of surgery | 
| Number of Participants Receiving Rescue Medication | Rescue medication defined as an antiemetic (or other medication) given with the intention of relieving nausea and/or emesis, or any incidental use of a drug known to have antiemetic potential | 24 hours after the end of surgery | 
| Number of Participants With Any Nausea | Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. Any nausea means a score ≥ 1. | 24 hours after the end of surgery | 
| Number of Participants With Significant Nausea | Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. Significant nausea means a score ≥ 4. | 24 hours after end of surgery | 
| Time to First Violation of Criteria for PONV | Criteria for PONV are any episode of emesis or use of rescue medication in the 24 hours after the end of surgery | 24 hours after end of surgery |