Fosaprepitant for Nausea and Vomiting

This study is looking at how well fosaprepitant 150 mg works to relieve nausea and vomiting compared to ondansetron 4 mg, which is a common treatment. Fosaprepitant works by blocking a specific signal in the brain that causes vomiting. We are looking for adults aged 18 and older who come to the emergency department with nausea and/or vomiting. We want to see if fosaprepitant helps you feel better within two hours, if there are any side effects, and if you need more medication. The study aims to enroll about 200 participants, but the current recruitment status is unclear.

Study design
This is a randomized, double-blind study, meaning participants are randomly assigned to receive either fosaprepitant or ondansetron, and neither you nor your doctor will know which treatment you are getting. The study plans to enroll 200 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your relief from nausea and vomiting, occurrence of side effects, and need for additional medication will be checked within two hours of receiving the study medication.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06382012

Antiemetic Fosaprepitant To Remedy Nausea and Vomiting

Recruiting
PHASE2Ages 18+InterventionalTreatment
Montefiore Medical Center
~200 participants
Updated 2026-05-18 on ClinicalTrials.gov
What's tested:Fosaprepitant 150 mgOndansetron 4 mg

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Relief from NV
Measured over Within 2 hours of medication administration
+2 more outcomes measured
Nausea and Vomiting
Nausea
Vomiting

NCT06382012

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Montefiore Medical Center (Montefiore and Weiler EDs)

    The Bronx, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Benjamin W Friedman, MD MS · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center

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Eligibility criteria

Inclusion

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

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
  • Relief from NVWithin 2 hours of medication administration

    Relief from nausea and vomiting will be determined by the intensity of nausea reported by participants following administration of antiemetic. Intensity of nausea will be reported as either "None," "Mild," "Moderate," or "Severe." Relief of nausea and vomiting requires a patient to present with a nausea intensity of either "Severe" or "Moderate," which is then reduced by treatment to at least "Mild" or "None," within two hours of medication administration, without the use or rescue medication. The number/percentage of participants who achieve relief from NV will be summarized by study arm.

  • Occurrence of any treatment-related adverse event2 hours following medication administration

    The primary safety/tolerability outcome for this study is the occurrence of any treatment related adverse event (TRAE) at 2 hours of medication administration. TRAEs - not including underlying pathology causing NV - and including, but not limited to: appendicitis, small bowel obstruction, constipation, gastroparesis, gastroenteritis, gastritis, will be summarized by study arm

  • Requirement for additional medication2 hours following medication administration

    Requirement of any additional medication specifically for treatment of NV at 2 hours of medication administration; the use of rescue medications to treat persistent NV, or other medications such as additional doses or use of adjunct medications will be recorded. The number/percentage of patients who require additional medication will be summarized by study arm.