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Neurokinin Inhibitor
Investigational Intervention for Vomiting (AFTR NV RCT Trial)
Phase 2 & 3
Waitlist Available
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
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
AFTR NV RCT Trial 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.Check my eligibility
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.See study design
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.
AFTR NV RCT Trial 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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Sustained Relief from NV
Secondary outcome measures
Fluid Treatment
Functional disability
Hospitalization
+8 moreAFTR NV RCT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Investigational InterventionExperimental Treatment1 Intervention
Fosaprepitant 150mg IV administered over 15 minutes
Group II: Standard-of-Care InterventionActive Control1 Intervention
Ondansetron 4mg IV administered over 15 minutes
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fosaprepitant 150 mg
2018
Completed Phase 4
~30
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Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
444 Previous Clinical Trials
582,310 Total Patients Enrolled
Benjamin W Friedman, MD MSPrincipal InvestigatorMontefiore Medical Center
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment for this study currently available to prospective participants?
"According to clinicaltrials.gov, this particular research endeavor is not currently in the recruitment phase. It was initially posted on June 1st, 2024, and last modified on April 19th, 2024. Nonetheless, it's worth noting that there are presently 109 alternative studies actively seeking eligible participants."
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