Home › Nausea and Vomiting › NCT06382012

Antiemetic Fosaprepitant To Remedy Nausea and Vomiting

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

About the study

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.

What is being tested

• Fosaprepitant 150 mg (drug)
• Ondansetron 4 mg (drug)

Sponsor: Montefiore Medical Center · Participants: 200 · Started: Nov 13, 2024

Contact the study team

• Mustfa K Manzur, MD MPH MS · Phone: 718-920-6626

Official record on ClinicalTrials.gov — NCT06382012

Locations in the U.S.

Conditions

• Nausea and Vomiting

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.