MedTrace Logo

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

NCT01363479 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 743

Last updated 2021-09-22

Study results available
· View outcomes & findings →

Summary

PALO-10-01 is a clinical study assessing efficacy and safety of a single oral dose of palonosetron compared to a single intravenous dose of palonosetron (Aloxi, an antiemetic drug), both given with oral dexamethasone. The objective of the study is to demonstrate that oral palonosetron 0.50 mg is as effective as (non-inferior to) palonosetron IV 0.25 mg to prevent nausea and vomiting induced by highly emetogenic cancer chemotherapy in the 0-24 hours after administration of a single cycle of highly emetogenic chemotherapy.

Conditions

  • Chemotherapy-Induced Nausea and Vomiting

Interventions

DRUG

Oral palonosetron

DRUG

I.V. 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
2011-07-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States
  • Argentina
  • Bulgaria
  • Croatia
  • Germany
  • Hungary
  • India
  • Italy
  • 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 NCT01363479 on ClinicalTrials.gov