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An Efficacy and Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting

NCT01339260 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1455

Last updated 2014-11-26

Study results available
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Summary

NETU-08-18 is a two-arm clinical study assessing efficacy and safety of a single oral dose of netupitant and palonosetron, two antiemetic drugs, versus oral palonosetron, both given with oral dexamethasone. The objective of the study is to demonstrate that netupitant and palonosetron are more effective than palonosetron alone, to prevent nausea and vomiting induced by moderately emetogenic cancer chemotherapy after administration of repeated cycles of chemotherapy.

Conditions

  • Chemotherapy-Induced Nausea and Vomiting

Interventions

DRUG

Netupitant and Palonosetron

DRUG

Palonosetron

DRUG

Dexamethasone

Sponsors & Collaborators

  • Parexel

    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
2011-04-30
Primary Completion
2012-11-30

Countries

  • United States
  • Argentina
  • Belarus
  • Brazil
  • Bulgaria
  • Croatia
  • Germany
  • Hungary
  • India
  • Italy
  • Mexico
  • Poland
  • Romania
  • Russia
  • 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 NCT01339260 on ClinicalTrials.gov