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A Safety Study of Intravenous Pro-Netupitant and Palonosetron Combination for the Prevention of Nausea and Vomiting

NCT02517021 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 405

Last updated 2018-06-20

Study results available
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Summary

NEPA-15-18 is a clinical study assessing safety of pro-netupitant and palonosetron, two antiemetic drugs, given with oral dexamethasone. The objective of the study is to evaluate if pro-netupitant and palonosetron are safe when administered to prevent nausea and vomiting after administration of repeated cycles of chemotherapy.

Conditions

  • Chemotherapy-Induced Nausea and Vomiting

Interventions

DRUG

Pro-netupitant/Palonosetron

DRUG

Netupitant/Palonosetron

DRUG

Dexamethasone

Sponsors & Collaborators

  • PSI CRO

    collaborator INDUSTRY

  • Helsinn Healthcare SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States
  • Austria
  • Croatia
  • Czechia
  • Germany
  • Israel
  • Italy
  • Poland
  • Serbia
  • South Africa
  • Spain
  • Ukraine

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 NCT02517021 on ClinicalTrials.gov