Phase IIIb Study of APD421 in Combination as PONV Prophylaxis

Status:	Completed
Conditions:	Hospital
Therapuetic Areas:	Other
Healthy:	No
Age Range:	18 - Any
Updated:	3/22/2019
Start Date:	February 2015
End Date:	September 2015

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).

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

We found this trial at

sites

University of Kansas Medical Center

3901 Rainbow Blvd
Kansas City, Kansas 66160

(913) 588-5000