Phase IIIb Study of APD421 in Combination as PONV Prophylaxis

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

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).

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 1147
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25030
    • University Hospital
  • Lyon, France, 69495
    • Centre hospitalier Lyon-Sud
  • Mulhouse, France, 68051
    • Centre Hospitalier de Mulhouse
  • Paris, France
    • Hôpital Foch
  • Strasbourg, France
    • CHU de Hautepierre
• Germany
  • Aue, Germany, 08280
    • Helios Klinikum Aue
  • Bonn, Germany, 53127
    • Universitätsklinikum Bonn
  • Ludwigshafen, Germany, 67063
    • Klinikum Ludwigshafen
  • Mainz, Germany, 55131
    • Universitätsmedizin Mainz
  • Marburg, Germany, 35033
    • Philipps University
  • Würzburg, Germany
    • University Hospitals of Würzburg
• United States
  • Alabama
    • Sheffield, Alabama, United States, 35660
      • Helen Keller Hospital
  • California
    • San Francisco, California, United States, 94143
      • UCSF School of Medicine
  • Florida
    • Miami, Florida, United States, 33136
      • Jackson Memorial Hospital
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center Hospital
    • Stony Brook, New York, United States, 11794
      • Stony Brook Medicine
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University School of Medicine
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Texas
    • Bellaire, Texas, United States, 77401
      • First Street Surgical Center
    • Houston, Texas, United States, 77004
      • Victory Medical Center Houston
    • Houston, Texas, United States, 77024
      • Memorial Hermann-Memorial City Hospital

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
• 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

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 + standard anti-emetic; Single dose of IV APD421	Drug: APD421
Placebo Comparator: Placebo + standard anti-emetic; Single dose of IV placebo	Drug: Placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Acacia Pharma Ltd
• Investigators: Principal Investigator: Peter Kranke, MD, Würzburg University Hospitals

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: January 9, 2015
• First Submitted That Met QC Criteria: January 12, 2015
• First Posted (Estimate): January 13, 2015

Study Record Updates

• Last Update Posted (Actual): March 20, 2019
• Last Update Submitted That Met QC Criteria: March 7, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: DP10017