US Phase III Study of APD421 in PONV

Randomized, 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: APD421- Amisulpride for IV injection; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 364
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States
      • Duke

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; APD421 (amisulpride), at 5mg given by single intravenous (IV) administration by slow push over one minute at induction of anaesthesia.	Drug: APD421- Amisulpride for IV injection; APD421 ( Amisulpride) at 5mg given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia; Other Names: Amisulpride for IV injection
Placebo Comparator: Placebo; Matching placebo given by single IV administration by slow push over one minute at induction of anaesthesia	Drug: Placebo; Matching Placebo given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Complete Response	The primary efficacy analysis was a comparison of the incidence of Complete Response, defined as no emesis (vomiting or retching) and no use of rescue medication in the 24 hours after the end of surgery, between the active group and the placebo group using Pearson χ2 test with Yates's continuity correction, and with a two-sided significance level of 5%.	24 hours after the end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With no 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. "No nausea" means no score ≥ 1.	24 hours after end of surgery
Number of Participants With no 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 end of surgery
Number of Participants With no Use of Rescue Medication	Any agent given in the post-operative period with the intention of providing anti-emetic rescue was counted as rescue anti-emetic medication for the purposes of efficacy determination, even if it did not achieve control of emesis or was given incorrectly (e.g., wrong dosage or route). Any agent given in the post-operative period which would be expected, by virtue of its pharmacology, dosage and route, to exert a clinically meaningful anti-emetic effect was considered as rescue anti-emetic medication, even if administered inadvertently or without the intention of providing rescue.	24 hours after end of surgery
The Number of Participants With no Emesis, no Significant Nausea and no Use of Rescue Medication	No occurrence of vomiting/retching, no nausea score ≥ 4 on verbal response scale (where 0=no nausea at all and 10=the worst nausea imaginable) and no use of rescue medication.	24 hours after the end of surgery
The Number of Participants With no 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. "No significant nausea" means no score ≥ 4.	24 hours after the end of surgery
Number of Participants With "Total Response"	Total response is defined as no occurrence of vomiting/retching, no nausea score ≥ 1 and no use of rescue medication.	24 hours after the end of surgery

Collaborators and Investigators

• Sponsor: Acacia Pharma Ltd
• Investigators: Principal Investigator: Tong J Gan, MD, Duke University Medical College

Study record dates

Study Major Dates

• Study Start: August 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): February 12, 2019
• Last Update Submitted That Met QC Criteria: January 18, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Dopamine Agents; Dopamine Antagonists; Antidepressive Agents, Second-Generation; Amisulpride
• Other Study ID Numbers: DP10015