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Pilot Study to Assess Palonosetron Versus Ondansetron as Rescue Medication in Subjects That Develop Postoperative Nausea and Vomiting (PONV) in the Postanesthesia Care Unit (PACU)

NCT00967499 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 239

Last updated 2021-01-11

Study results available
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Summary

The purpose of this study is to investigate palonosetron versus ondansetron as rescue medication in subjects that develop postoperative nausea and vomiting (PONV) in the Postanaesthesia Care Unit (PACU).

Conditions

  • Postoperative Nausea and Vomiting

Interventions

DRUG

Ondansetron

Subjects will receive ondansetron 4 mg intravenously (IV) and will be followed for 72 hours. Ondansetron is a selective 5-HT3 receptor antagonist. It is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin and prevention of postoperative nausea and/or vomiting.

DRUG

Palonosetron

Subjects will receive palonosetron HCl 0.075 mg IV and will be followed for 72 hours. Palonosetron hydrochloride (Aloxi®) is a potent and selective 5-HT3 receptor antagonist for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy, the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy, and the prevention of postoperative nausea and vomiting for up to 24 hours following surgery.

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-13
Primary Completion
2009-12-18
Completion
2009-12-18

Countries

  • United States

Study Locations

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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 NCT00967499 on ClinicalTrials.gov