Recruiting
Phase 2
Phase 3

Fosaprepitant

Sponsor:

Montefiore Medical Center

Code:

NCT06382012

Conditions

Nausea and Vomiting

Nausea

Vomiting

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fosaprepitant 150 mg

Ondansetron 4 mg

Study Details

Brief summary:

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.

Conditions

Nausea and Vomiting

Nausea

Vomiting

Study ID

NCT06382012

Start date

Nov 13, 2024

Status verified date

May, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Investigational Intervention

Fosaprepitant 150mg IV administered over 15 minutes

active comparator: Standard-of-Care Intervention

Ondansetron 4mg IV administered over 15 minutes

Interventions

Fosaprepitant 150 mg

Fosaprepitant 150mg IV administered over 15 minutes

Ondansetron 4 mg

Ondansetron 4mg IV administered over 15 minutes

Primary outcome measure

  • Relief from NV [ Time Frame: Within 2 hours of medication administration ]
  • Occurrence of any treatment-related adverse event [ Time Frame: 2 hours following medication administration ]
  • Requirement for additional medication [ Time Frame: 2 hours following medication administration ]

Central Contacts and Locations

Central contacts

Mustfa K Manzur, MD MPH MS

718-920-6626mmanzur@montefiore.org

Locations

Montefiore Medical Center (Montefiore and Weiler EDs)

Recruiting

The Bronx, New York, United States, 10467

Contacts

More Information

Sponsor

Montefiore Medical Center

Last update posted

May 18, 2026

Last verified

May, 2026

Keywords

  • Fosaprepitant
  • Vomiting
  • Randomized Control Trial
  • Ondansetron
  • Adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-05-18.