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Antiemetic Fosaprepitant To Remedy Nausea and Vomiting

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllMontefiore Medical Center
NCT06382012 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 i

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📋 Eligibility rules (as published)
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
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What it tests

  • Fosaprepitant 150 mg
  • Ondansetron 4 mg
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Where

1 site
Montefiore Medical Center (Montefiore and Weiler EDs)
The Bronx, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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