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Antiemetic Fosaprepitant To Remedy Nausea and Vomiting

Study acronym: AFTR NV RCT
StatusRecruiting
PhasePhase 2/3
Started
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Record History

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  1. Notable Primary and study completion dates: Jun 2026 to Mar 2027
    • Primary endpoints: 1 to 3
    • Enrollment target: 250 to 200
    • Secondary endpoints: 11 to 6
    v8
  2. Notable Primary and study completion dates: May 2025 to Jun 2026
    • Eligibility criteria expanded, about 38 words
    v7
  3. Minor Start date changed from estimate of Nov 2024 to Nov 13, 2024
    • Eligibility criteria shortened, about 2 words
    v6
  4. Minor Primary and study completion dates: Apr 2025 to May 2025
    • Start date: Oct 2024 to Nov 2024
    v5
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Aug 2024 to Oct 2024
    • Primary and study completion dates: Feb 2025 to Apr 2025
    • Site details revised
    v4
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  1. Notable Start date: Jun 2024 to Aug 2024
    • Primary and study completion dates: Dec 2024 to Feb 2025
    v3
  2. Minor Study completion date: May 2025 to Dec 2024
    • Secondary endpoints revised (11)
    • Study description revised
    • Study title shortened, about 4 words
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06382012
Lead Sponsor Montefiore Medical Center
Conditions
(from sponsor)
Nausea and Vomiting, Nausea, Vomiting
Related terms Nausea, Vomiting
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov