Fosaprepitant vs Metoclopramide for Nausea and Vomiting
(BARF RCT Trial)

Recruiting in Palo Alto (17 mi)

Dr. Benjamin W. Friedman, MD | Bronx ...

Overseen byBenjamin W Friedman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Montefiore Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of 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.

Research Team

Benjamin W Friedman, MD

Principal Investigator

Montefiore Medical Center

Eligibility Criteria

This trial is for adults over 18 who come to the emergency department with nausea and/or vomiting. They must be able to speak English or Spanish, have a phone for follow-up, and not be pregnant, lactating, or wanting pregnancy. Excluded are those with recent antiemetic use, bradycardia, prolonged QTc on ECG, altered mental status or dementia.

Inclusion Criteria

I am 18 years old or older.

I went to the emergency department for nausea or vomiting.

Exclusion Criteria

Pregnancy, desiring pregnancy, or lactating

Bradycardia (< 60 bpm heart rate)

Prolonged QTc (greater than 490ms)

See 5 more

Treatment Details

Interventions

Fosaprepitant (Neurokinin Inhibitor)
Metoclopramide (Dopamine Antagonist)

Trial OverviewThe study compares fosaprepitant's effectiveness against metoclopramide in treating nausea and vomiting. It's a double-blind RCT where neither doctors nor patients know who gets which drug. Fosaprepitant acts on the brain to block signals that cause vomiting and could be cheaper than current treatments.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Investigational InterventionExperimental Treatment1 Intervention

Fosaprepitant

Group II: Standard-of-Care InterventionActive Control1 Intervention

Metoclopramide