At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 568 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 Study of APD421 (Amisulpride for IV Injection) as Treatment of Established Post-operative Nausea and Vomiting, in Patients Who Have Had no Prior Prophylaxis
In Brief
A Phase 3 clinical trial evaluating APD421 and Placebo for Postoperative Nausea and Vomiting. Completed, enrolled 568 participants across 4 sites in 3 countries.
Detailed Summary
Double-blind, randomised, parallel-group, placebo-controlled, adaptive, seamless, dose-selecting study to compare the efficacy of APD421 to placebo as treatment of established PONV, in patients who have not had prior PONV prophylaxis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Nausea and Vomiting
CountriesFrance, Germany, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 2015
Enrollment StartSep 2015
Primary CompletionJul 2016
TodayJul 2026
First PostedMay 20, 2015
Enrollment StartSep 1, 2015
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 11.1 years ago
Interventions
APD421drug
Placebodrug