Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382012
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-19
Brief Title:
Antiemetic Fosaprepitant To Remedy Nausea and Vomiting
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
Antiemetic Fosaprepitant To Remedy Nausea and Vomiting
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AFTR NV RCT
Brief Summary:
The study team proposes a randomized double-blind RCT to address the following goal to determine the relative efficacy and adverse event profile of fosaprepitant compared to the standard of care antiemetic ondansetron Fosaprepitant and its active metabolite aprepitant are a relatively new class of antiemetic that exclusively acts in the central nervous system by blocking neurokinin NK-1 which is a key signaling molecule in the centrally mediated aspects of the vomiting reflex Currently fosaprepitant and aprepitant both have only two United Stated Food and Drug Administration USFDA approved indications for nausea and vomiting chemotherapy-induced and postoperative Neurokinin inhibitors are highly effective and generally well-tolerated Therefore this class of medication may be a more appropriate medication for the millions of patients with nausea and vomiting that seek care in EDs Intravenous fosaprepitant is converted to the active metabolite aprepitant on the order of minutes and is significantly cheaper to procure at this time The outcome for the efficacy analysis will be no need for additional medication to treat nausea and vomiting within 2 hours of investigational medication administration The primary outcome for the tolerability analysis will be the development of any new symptom within 2 hours of medication administration
Detailed Description:
Nausea and vomiting NV are common and interrelated conditions Approximately 50 of adults experience nausea in a given year while 30 of adults experience vomiting over the same period Of this population of symptomatic individuals with NV 25 of patients seek care in any healthcare delivery setting Health Care Utilization Project HCUP data indicates that nearly 90 million patients seek care for NV in emergency departments EDs each year in the United States
Antiemetics are used to treat NV Antiemetics currently utilized in the emergency department setting for NV do not always work on the first dose and have a plethora of side effects because of their peripheral mechanism of action outside of the vomiting reflex pathway in the central nervous system These medications include ondansetron promethazine metoclopramide olanzapine haloperidol Chief among these side effects is alteration of an aspect cardiac electrical signaling called the QT segment which represents the duration of ventricular contraction and relaxation The QT segment is prolonged with commonly used antiemetics which can often be a prelude to cardiac dysrhythmias that are associated with mortality As a result patients with NV often have long length-of-stay LOS involving supportive care with intravenous fluids or empiric treatment with medications that can potentiate development of cardiac dysrhythmias This is a problem in busy emergency departments EDs struggling to accelerate patient throughput in order to appropriately keep up with patient volume in an under-supplied hospital bed environment nationally
Fosaprepitant and its active metabolite aprepitant are a relatively new class of antiemetic that exclusively acts in the central nervous system by blocking neurokinin NK-1 which is a key signaling molecule in the centrally mediated aspects of the vomiting reflex Currently fosaprepitant and aprepitant both have only two United Stated Food and Drug Administration USFDA approved indications for nausea and vomiting chemotherapy-induced and postoperative Neurokinin inhibitors are highly effective and generally well-tolerated Therefore this class of medication may be a more appropriate medication for the millions of patients with nausea and vomiting that seek care in EDs Intravenous fosaprepitant is converted to the active metabolite aprepitant on the order of minutes and is significantly cheaper to procure at this time
Antiemetics are used to treat NV Antiemetics currently utilized in the emergency department setting for NV do not always work on the first dose and have a plethora of side effects because of their peripheral mechanism of action outside of the vomiting reflex pathway in the central nervous system These medications include ondansetron promethazine metoclopramide olanzapine haloperidol Chief among these side effects is alteration of an aspect cardiac electrical signaling called the QT segment which represents the duration of ventricular contraction and relaxation The QT segment is prolonged with commonly used antiemetics which can often be a prelude to cardiac dysrhythmias that are associated with mortality As a result patients with NV often have long length-of-stay LOS involving supportive care with intravenous fluids or empiric treatment with medications that can potentiate development of cardiac dysrhythmias This is a problem in busy emergency departments EDs struggling to accelerate patient throughput in order to appropriately keep up with patient volume in an under-supplied hospital bed environment nationally
Fosaprepitant and its active metabolite aprepitant are a relatively new class of antiemetic that exclusively acts in the central nervous system by blocking neurokinin NK-1 which is a key signaling molecule in the centrally mediated aspects of the vomiting reflex Currently fosaprepitant and aprepitant both have only two United Stated Food and Drug Administration USFDA approved indications for nausea and vomiting chemotherapy-induced and postoperative Neurokinin inhibitors are highly effective and generally well-tolerated Therefore this class of medication may be a more appropriate medication for the millions of patients with nausea and vomiting that seek care in EDs Intravenous fosaprepitant is converted to the active metabolite aprepitant on the order of minutes and is significantly cheaper to procure at this time
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None