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.
Antiemetic Fosaprepitant To Remedy Nausea and Vomiting
At a glance
Conditions
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.
Study leadership
- Benjamin W Friedman, MD MS · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center
Who to contact
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Inclusion
Exclusion
What this trial measures
- 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.