At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 342 enrolled
Drug / intervention
Ondansetron +5 moredrug
Likely dose
APD403 IV 20 mgfrom 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, Dose-finding Phase II Study to Assess the Efficacy of APD403 in the Prevention of Nausea and Vomiting Caused by Cisplatin- or Anthracycline/Cyclophosphamide (AC)-Based Chemotherapy
In Brief
A Phase 2 clinical trial evaluating Ondansetron, Placebo, and 4 other interventions for CINV. Completed, enrolled 342 participants across 1 site.
Detailed Summary
Comparison of efficacy of APD403 at preventing delayed sickness in patients who have received cancer chemotherapy
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCINV
CountriesDenmark
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 2013
Enrollment StartOct 2013
Primary CompletionFeb 2015
TodayJul 2026
First PostedMay 20, 2013
Enrollment StartOct 1, 2013
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.1 years ago
Interventions
Ondansetrondrug
5HT3-antagonist
Placebodrug
Comparator
Dexamethasonedrug
Corticosteroid
Fosaprepitantdrug
NK1 antagonist
APD403 IVdrug
Amisulpride IV 20 mg
APD403 oraldrug
Amisulpride oral 10, 20 or 40 mg