CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,154 enrolled
Drug / intervention
palonosetron, dexamethasone, and fosaprepitant dissolved in 0.9% NaCl +1 moredrug
Likely dose
palonosetron, dexamethasone, and fosaprepitant dissolved in 0.9% NaCl 0.075 mgfrom record
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Search/NCT04853147
NCT04853147Phase 3Completed

Triple Combination of Fosaprepitant, Dexamethasone and Palonosetron Versus Combination of Dexamethasone and Palonosetron for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gastrointestinal Surgery

Sixth Affiliated Hospital, Sun Yat-sen University·interventional·Posted Apr 21, 2021·Updated Dec 29, 2022

In Brief

A Phase 3 clinical trial evaluating palonosetron, dexamethasone, and fosaprepitant dissolved in 0.9% NaCl and palonosetron, dexamethasone, and 0.9% NaCl for C.Surgical Procedure; Gastrointestinal. Completed, enrolled 1,154 participants across 1 site.

Detailed Summary

Postoperative nausea and vomiting (PONV) are common in patients, especially in patients at high risk. PONV may result in prolonged hospital stay and threaten patients' life. Because the etiology of PONV is very complex, there is an increasing focus on combining antiemetics from different classes for PONV prophylaxis. Fosaprepitant is a neurokinin-1 (NK-1) receptor antagonist to prevent PONV. Palonosetron is a 5-HT3 receptor antagonist with high efficacy and sustained action for PONV prophylaxis. Dexamethasone belongs to corticosteroid and also has the ability to reduce the incident of PONV. This study aims to use the combination of these three drugs in high-risk patients to test whether triple therapy is better than combination of palonosetron and dexamethasone to prevent PONV.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedApr 21, 2021
Enrollment StartApr 27, 2021
Primary CompletionApr 13, 2022
Study CompletionOct 12, 2022
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 5.2 years ago

Interventions

palonosetron, dexamethasone, and fosaprepitant dissolved in 0.9% NaCldrug

palonosetron 0.075 mg, iv, dexamethasone 5mg, iv, fosaprepitant 150mg dissolved in 0.9% NaCl 150ml, iv.drip,

palonosetron, dexamethasone, and 0.9% NaCldrug

palonosetron 0.075 mg, iv, dexamethasone 5mg, iv, 0.9% NaCl 150ml, iv.drip,