Actively Recruiting
Antiemetic Fosaprepitant To Remedy Nausea and Vomiting
Led by Montefiore Medical Center · Updated on 2025-08-29
250
Participants Needed
1
Research Sites
80 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Antiemetic Fosaprepitant To Remedy Nausea and Vomiting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults at least 18 years old
- Present to an emergency department (ED) for nausea and/or vomiting as defined by the International Classification of Diseases (ICD-10), or identified by treating clinician
- Following protocol amendment approval, patients who received an antiemetic and remain nauseated after 2 hours are eligible
You will not qualify if you...
- Pregnancy, desiring pregnancy, or lactating
- Antiemetic medication use less than 2 hours prior to screening
- Bradycardia (heart rate less than 60 bpm)
- Prolonged QTc (>480ms)
- Not conversant in English or Spanish
- Altered mental status
- Dementia
- Lack of phone for follow-up communication
AI-Screening
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Trial Site Locations
Total: 1 location
1
Montefiore Medical Center (Montefiore and Weiler EDs)
The Bronx, New York, United States, 10467
Actively Recruiting
Research Team
M
Mustfa K Manzur, MD MPH MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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