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NCT06382012 · ClinicalTrials.gov registry record · Phase 2
Antiemetic Fosaprepitant To Remedy Nausea and Vomiting
A Phase 2 study of Nausea and Vomiting, sponsored by Montefiore Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 250
- Enrollment target
- 1
- Study location
NCT06382012: Recruiting Phase 2 study of Nausea and Vomiting, sponsored by Montefiore Medical Center.
NCT06382012 is a Phase 2 study of Nausea and Vomiting that is actively recruiting participants, run by Montefiore Medical Center. The registered enrollment target is 250 participants, roughly in line with the 229-participant average among 17 other Nausea trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06382012, a Phase 2 study of Nausea and Vomiting, is actively recruiting participants, sponsored by Montefiore Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 250 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Relief from nausea and vomiting will be determined by the intensity of nausea reported by participants following administration of antiemetic. Intensity of nausea will be reported as either "None," "Mild," "Moderate," or "Severe." Relief of nausea and vomiting requires a patient to present with a nausea intensity of either "Severe" or "Moderate," which is then reduced by treatment to at least "Mild" or "None," within two hours of medication administration, without the use or rescue medication. T
Conditions Studied
Interventions
- DRUG Fosaprepitant 150 mg
- DRUG Ondansetron 4 mg
Study Locations (1)
New York
- Montefiore Medical Center (Montefiore and Weiler EDs) - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2024-11-13 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
What NCT06382012 shows while recruiting
NCT06382012 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 229-participant average among 17 other Nausea trials with a reported enrollment target.
The record links to 3 conditions, with Nausea appearing as the primary indexed condition, and to 2 interventions - of which Fosaprepitant 150 mg is the first listed.
NCT06382012 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06382012 about?
NCT06382012 is a clinical study titled "Antiemetic Fosaprepitant To Remedy Nausea and Vomiting". 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 ...
What is the current status of trial NCT06382012?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 250 participants. The study started on 2024-11-13. Estimated completion is 2026-06.
What conditions does trial NCT06382012 study?
This clinical trial studies the following conditions: Nausea, Vomiting, Nausea and Vomiting.
What interventions are being tested in trial NCT06382012?
The interventions under investigation include: Fosaprepitant 150 mg (DRUG), Ondansetron 4 mg (DRUG).
Who is sponsoring clinical trial NCT06382012?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06382012 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Nausea
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06382012's enrollment target sits among peer trials
250 4th of 17 higher than 14 of 17 other Nausea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Nausea trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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