At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 364 enrolled
Drug / intervention
APD421- Amisulpride for IV injection +1 moredrug
Likely dose
APD421- Amisulpride for IV injection 5mgfrom 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.
Randomized, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Prophylaxis Against Post-operative Nausea and Vomiting
In Brief
A Phase 3 clinical trial evaluating APD421- Amisulpride for IV injection and Placebo for PONV. Completed, enrolled 364 participants across 1 site.
Detailed Summary
A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPONV
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartAug 2013
First PostedNov 2013
Primary CompletionJan 2014
TodayJul 2026
First PostedNov 25, 2013
Enrollment StartAug 1, 2013
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 12.6 years ago
Interventions
APD421- Amisulpride for IV injectiondrug
APD421 ( Amisulpride) at 5mg given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia
Placebodrug
Matching Placebo given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia