Clinical Trials Directory

Trials / Completed

CompletedNCT01857232

Dose-finding Study of APD403 to Prevent Nausea and Vomiting After Chemotherapy

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
342 (actual)
Sponsor
Acacia Pharma Ltd · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Comparison of efficacy of APD403 at preventing delayed sickness in patients who have received cancer chemotherapy

Conditions

Interventions

TypeNameDescription
DRUGOndansetron5HT3-antagonist
DRUGPlaceboComparator
DRUGDexamethasoneCorticosteroid
DRUGFosaprepitantNK1 antagonist
DRUGAPD403 IVAmisulpride IV 20 mg
DRUGAPD403 oralAmisulpride oral 10, 20 or 40 mg

Timeline

Start date
2013-10-01
Primary completion
2015-02-01
Completion
2015-02-01
First posted
2013-05-20
Last updated
2020-11-25
Results posted
2019-03-12

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT01857232. Inclusion in this directory is not an endorsement.

Dose-finding Study of APD403 to Prevent Nausea and Vomiting After Chemotherapy (NCT01857232) · Clinical Trials Directory