Broadening Antiemetics Research by Comparing the Effectiveness of Fosaprepitant and Metoclopramide

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontefiore Medical Center

About this trial

The study team proposes a double-blind, comparative effectiveness, randomized controlled trial (RCT) to address the following goal: to determine the relative efficacy and adverse event profile of fosaprepitant compared to the standard of care antiemetic metoclopramide. 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 emergency departments (EDs). Intravenous fosaprepitant is converted to the active metabolite aprepitant on the order of minutes and is significantly cheaper to procure at this time.

Eligibility criteria

Qualifiers

Adults at least 18 years old

Present to ED for treatment of Nausea and/or vomiting as defined by the International Classification of Diseases (ICD-10) or identified by treating clinician

Disqualifiers

Pregnancy, desiring pregnancy, or lactating

Antiemetic use or intravenous fluids prior to presenting to ED for evaluation and management

Bradycardia (< 60 bpm heart rate)

Prolonged QTc (greater than 490ms)

Trial design

Treatments tested in this trial

  • Fosaprepitant for Injection
  • Metoclopramide Injection

Treatment groups

212 Participants
are divided into 2 treatment groups

Sponsors and collaborators