Phase IIIb Study of APD421 in Combination as PONV Prophylaxis
NCT ID: NCT02337062
Last Updated: 2019-03-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1147 participants
INTERVENTIONAL
2015-02-28
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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APD421 + standard anti-emetic
Single dose of IV APD421
APD421
Placebo + standard anti-emetic
Single dose of IV placebo
Placebo
Interventions
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APD421
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Acacia Pharma Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Kranke, MD
Role: PRINCIPAL_INVESTIGATOR
Würzburg University Hospitals
Locations
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Helen Keller Hospital
Sheffield, Alabama, United States
UCSF School of Medicine
San Francisco, California, United States
Jackson Memorial Hospital
Miami, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Albany Medical Center Hospital
Albany, New York, United States
Stony Brook Medicine
Stony Brook, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
First Street Surgical Center
Bellaire, Texas, United States
Victory Medical Center Houston
Houston, Texas, United States
Memorial Hermann-Memorial City Hospital
Houston, Texas, United States
University Hospital
Besançon, , France
Centre Hospitalier Lyon-Sud
Lyon, , France
Centre Hospitalier de Mulhouse
Mulhouse, , France
Hopital Foch
Paris, , France
CHU de Hautepierre
Strasbourg, , France
HELIOS Klinikum Aue
Aue, , Germany
Universitätsklinikum Bonn
Bonn, , Germany
Klinikum Ludwigshafen
Ludwigshafen, , Germany
Universitätsmedizin Mainz
Mainz, , Germany
Philipps University
Marburg, , Germany
University Hospitals of Würzburg
Würzburg, , Germany
Countries
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Other Identifiers
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DP10017
Identifier Type: -
Identifier Source: org_study_id
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