MedTrace Logo

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

NCT01857232 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2020-11-25

Study results available
· View outcomes & findings →

Summary

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

Conditions

  • CINV

Interventions

DRUG

Ondansetron

5HT3-antagonist

DRUG

Placebo

Comparator

DRUG

Dexamethasone

Corticosteroid

DRUG

Fosaprepitant

NK1 antagonist

DRUG

APD403 IV

Amisulpride IV 20 mg

DRUG

APD403 oral

Amisulpride oral 10, 20 or 40 mg

Sponsors & Collaborators

  • Acacia Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Jørn Herrstedt, MD · Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01857232 on ClinicalTrials.gov