Clinical trial NCT02337062: Phase IIIb Study of APD421 in Combination as PONV Prophylaxis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: PONV
Lead sponsor: Acacia Pharma Ltd
Sponsor class: INDUSTRY
First posted: 2015-01-13
Enrollment: 1147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Complete Response
timeFrame: 24 hours after the end of surgery
Secondary outcomes:
measure: Number of Participants With Emesis
timeFrame: 24 hours after the end of surgery
measure: Number of Participants Receiving Rescue Medication
timeFrame: 24 hours after the end of surgery
measure: Number of Participants With Any Nausea
timeFrame: 24 hours after the end of surgery
measure: Number of Participants With Significant Nausea
timeFrame: 24 hours after end of surgery
measure: Time to First Violation of Criteria for PONV
timeFrame: 24 hours after end of surgery
Other outcomes:
Locations:
city: Sheffield
country: United States
facility: Helen Keller Hospital
state: Alabama
city: San Francisco
country: United States
facility: UCSF School of Medicine
state: California
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Albany
country: United States
facility: Albany Medical Center Hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Medicine
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Bellaire
country: United States
facility: First Street Surgical Center
state: Texas
city: Houston
country: United States
facility: Victory Medical Center Houston
state: Texas
city: Houston
country: United States
facility: Memorial Hermann-Memorial City Hospital
state: Texas
city: Besançon
country: France
facility: University Hospital
city: Lyon
country: France
facility: Centre Hospitalier Lyon-Sud
city: Mulhouse
country: France
facility: Centre Hospitalier de Mulhouse
city: Paris
country: France
facility: Hopital Foch
city: Strasbourg
country: France
facility: CHU de Hautepierre
city: Aue
country: Germany
facility: HELIOS Klinikum Aue
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Ludwigshafen
country: Germany
facility: Klinikum Ludwigshafen
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz
city: Marburg
country: Germany
facility: Philipps University
city: Würzburg
country: Germany
facility: University Hospitals of Würzburg
Study officials:
affiliation: Würzburg University Hospitals
name: Peter Kranke, MD
role: PRINCIPAL_INVESTIGATOR
References: