Antiemetic Fosaprepitant To Remedy Nausea and Vomiting
Recruiting now · Phase 2/Phase 3
Conditions studied: Nausea and Vomiting, Nausea, Vomiting
In brief
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.
Key facts
- Study ID
- NCT06382012
- Run by
- Montefiore Medical Center
- People needed
- 200
- Starts
- 2024-11-13
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-05-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 the approval of a protocol amendment, study patients who have received an antiemetic and remain persistently nauseated after 2 hours will be eligible to participate in the study
You may not qualify if…
- Pregnancy, desiring pregnancy, or lactating
- Antiemetic medication use less than 2 hours prior to screening
- Bradycardia (heart rate less than 60 bpm heart rate)
- Prolonged QTc (>480ms)
- Not conversant in English or Spanish
- Altered mental status
- Dementia
- Lack of phone for follow-up communication
Where it is running
- Montefiore Medical Center (Montefiore and Weiler EDs) — The Bronx, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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