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
1 other identifier
interventional
1,147
3 countries
25
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2015
Shorter than P25 for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2015
CompletedFirst Posted
Study publicly available on registry
January 13, 2015
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
August 4, 2017
CompletedMarch 20, 2019
March 1, 2019
7 months
January 9, 2015
July 7, 2017
March 7, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Number of Participants With Emesis
24 hours after the end of surgery
Number of Participants Receiving Rescue Medication
24 hours after the end of surgery
Number of Participants With Any Nausea
24 hours after the end of surgery
Number of Participants With Significant Nausea
24 hours after end of surgery
Time to First Violation of Criteria for PONV
24 hours after end of surgery
Study Arms (2)
APD421 + standard anti-emetic
EXPERIMENTALSingle dose of IV APD421
Placebo + standard anti-emetic
PLACEBO COMPARATORSingle dose of IV placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Helen Keller Hospital
Sheffield, Alabama, 35660, United States
UCSF School of Medicine
San Francisco, California, 94143, United States
Jackson Memorial Hospital
Miami, Florida, 33136, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Albany Medical Center Hospital
Albany, New York, 12208, United States
Stony Brook Medicine
Stony Brook, New York, 11794, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
First Street Surgical Center
Bellaire, Texas, 77401, United States
Victory Medical Center Houston
Houston, Texas, 77004, United States
Memorial Hermann-Memorial City Hospital
Houston, Texas, 77024, United States
University Hospital
Besançon, 25030, France
Centre Hospitalier Lyon-Sud
Lyon, 69495, France
Centre Hospitalier de Mulhouse
Mulhouse, 68051, France
Hopital Foch
Paris, France
CHU de Hautepierre
Strasbourg, France
HELIOS Klinikum Aue
Aue, 08280, Germany
Universitätsklinikum Bonn
Bonn, 53127, Germany
Klinikum Ludwigshafen
Ludwigshafen, 67063, Germany
Universitätsmedizin Mainz
Mainz, 55131, Germany
Philipps University
Marburg, 35033, Germany
University Hospitals of Würzburg
Würzburg, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
There were no limitations and caveats that occurred during the duration of this study.
Results Point of Contact
- Title
- Dr Gabriel Fox
- Organization
- Acacia Pharma Ltd
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Kranke, MD
Würzburg University Hospitals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2015
First Posted
January 13, 2015
Study Start
February 1, 2015
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
March 20, 2019
Results First Posted
August 4, 2017
Record last verified: 2019-03