CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 239 enrolled
Drug / intervention
Ondansetron +1 moredrug
Likely dose
Ondansetron 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00967499
NCT00967499Phase 2Completed
CompareCT.gov

A Multi-Center, Open-Label, 2-Arm, Randomized, Stratified, Parallel, Pilot Study to Assess Palonosetron vs. Ondansetron as Rescue Medication in Subjects That Develop Postoperative Nausea and Vomiting (PONV) in the Postanesthesia Care Unit (PACU)

Eisai Inc.·interventional·Posted Aug 28, 2009·Updated Jan 11, 2021

In Brief

A Phase 2 clinical trial evaluating Ondansetron and Palonosetron for Postoperative Nausea and Vomiting. Completed, enrolled 239 participants across 8 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Nausea and Vomiting
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 28, 2009
Enrollment StartJul 13, 2009
Primary CompletionDec 18, 2009
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.8 years ago

Interventions

Ondansetrondrug

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.

Palonosetrondrug

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.