Phase IIIb Study of APD421 in Combination as PONV Prophylaxis

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).


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Enrollment: 1204
Study Start Date: February 2015
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

Arms:
- Experimental: APD421 + standard anti-emetic
- Placebo Comparator: Placebo + standard anti-emetic