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An Efficacy and Safety Study of Intravenous Palonosetron Administered as an Infusion and as a Bolus for the Prevention of Nausea and Vomiting

NCT02557035 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 441

Last updated 2018-06-20

Study results available
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Summary

PALO-15-17 is a clinical study assessing efficacy and safety of a single dose of palonosetron 0.25 mg administered as a 30-minute IV infusion compared to palonosetron 0.25 mg administered as a 30-second IV bolus (Aloxi, an antiemetic drug), both given with oral dexamethasone. The objective of the study is to demonstrate that infused IV palonosetron 0.25 mg is as effective as (non-inferior to) injected 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

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
2015-10-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Belarus
  • Bosnia and Herzegovina
  • Bulgaria
  • Georgia
  • Greece
  • Hungary
  • Lithuania
  • Romania
  • Russia

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 NCT02557035 on ClinicalTrials.gov