Phase IIIb Study of APD421 in Combination as PONV Prophylaxis

Completed · Phase 3 · Has a placebo group

Conditions studied: PONV

In brief

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).

Key facts

Study ID

NCT02337062

Run by

Acacia Pharma Ltd

People needed

1147

Starts

2015-02-01

Expected to finish

2015-09-01

Last updated by the study team

2019-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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