Antiemetic Fosaprepitant To Remedy Nausea and Vomiting

Part of paid clinical trials in The Bronx, New York.

Sponsor
Montefiore Medical Center
Study ID
NCT06382012
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Nausea
  • Nausea and Vomiting
  • Vomiting

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fosaprepitant 150 mg — DRUG
    Fosaprepitant 150mg IV administered over 15 minutes
  • Ondansetron 4 mg — DRUG
    Ondansetron 4mg IV administered over 15 minutes

Study Details

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.

Key Dates

Start date
Nov 13, 2024
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Investigational Intervention
    Fosaprepitant 150mg IV administered over 15 minutes
  • Active Comparator: Standard-of-Care Intervention
    Ondansetron 4mg IV administered over 15 minutes

Primary Outcome Measure

Relief from NV [ Time Frame: Within 2 hours of medication administration ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Medical Center (Montefiore and Weiler EDs)The BronxNew York10467
Mustfa K Manzur, MD
[email protected]
718-920-6626

Find similar trials in The Bronx, NY

By research site
Montefiore Medical Center (Montefiore and Weiler EDs)· The Bronx, NY

Related Studies