Fosaprepitant for Nausea and Vomiting (AFTR NV RCT Trial)

Phase 2 & 3

Recruiting

Led By Benjamin W Friedman, MD MS

Research Sponsored by Montefiore Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Not conversant in English or Spanish

Altered mental status

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours (measured every 15 minutes for the first 2 hours, then hourly after that until disposition; reassessed at 24 hours)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare the effectiveness and side effects of fosaprepitant, a new antiemetic medication, with the standard medication ondansetron. Fosaprepitant works in

Who is the study for?

This trial is for patients experiencing nausea and vomiting who are seeking a potentially more effective treatment. Participants should not have used any other antiemetic medication recently and must be in need of immediate relief from their symptoms.

What is being tested?

The study compares the effectiveness of Fosaprepitant, a newer antiemetic drug, with Ondansetron, a standard treatment. It's randomized and double-blind, meaning neither the doctors nor patients know who gets which drug to ensure unbiased results.

What are the potential side effects?

Fosaprepitant may cause side effects such as headaches or dizziness due to its action in the central nervous system. Since it blocks specific signals that trigger vomiting, there might also be unexpected reactions within two hours of taking it.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot speak English or Spanish.

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I have experienced changes in my mental state.

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I have used anti-nausea medication or received IV fluids before screening.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours (measured every 15 minutes for the first 2 hours, then hourly after that until disposition; reassessed at 24 hours)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours (measured every 15 minutes for the first 2 hours, then hourly after that until disposition; reassessed at 24 hours)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours (measured every 15 minutes for the first 2 hours, then hourly after that until disposition; reassessed at 24 hours) for reporting.