At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,147 enrolled
Drug / intervention
APD421 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating APD421 and Placebo for PONV. Completed, enrolled 1,147 participants across 25 sites in 3 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPONV
CountriesFrance, Germany, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 2015
Enrollment StartFeb 2015
Primary CompletionSep 2015
TodayJul 2026
First PostedJan 13, 2015
Enrollment StartFeb 1, 2015
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.5 years ago
Interventions
APD421drug
Placebodrug