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NCT04054193 · ClinicalTrials.gov registry record · Phase 4
Safety of a Three-Day Fosaprepitant Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-045)
A Phase 4 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 4
- Development phase
- 103
- Enrollment target
NCT04054193: Completed Phase 4 study, sponsored by Merck Sharp & Dohme.
NCT04054193 is a Phase 4 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 103 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04054193, a Phase 4 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 103 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and tolerability of a 3-day intravenous (IV) fosaprepitant dimeglumine (MK-0517) regimen for the prevention of CINV in pediatric participants scheduled to receive emetogenic chemotherapy. Each participant was enrolled in Cycle 1 (on which the primary study objectives were based), consisting of the 3-day treatment cycle and 14 days of follow-up for a total of 17 days.
Primary Outcome
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. The percentage of participants in Cycle 1 who experience one or more AE(s) is presented.
Interventions
- DRUG Dexamethasone
- DRUG Fosaprepitant Dimeglumine
- DRUG 5-HT3 antagonist
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2019-09-09 |
| Est. Completion | 2021-02-11 |
| Phase | Phase 4 |
What the finished NCT04054193 record still lists
NCT04054193 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.
NCT04054193 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04054193 about?
NCT04054193 is a clinical study titled "Safety of a Three-Day Fosaprepitant Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-045)". The purpose of this study is to evaluate the safety and tolerability of a 3-day intravenous (IV) fosaprepitant dimeglumine (MK-0517) regimen for the prevention of CINV in pediatric participants scheduled to receive emetogenic chemotherapy. Each participant was enrolled in Cycle 1 (on which the prima...
What is the current status of trial NCT04054193?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 103 participants. The study started on 2019-09-09. Estimated completion is 2021-02-11.
What interventions are being tested in trial NCT04054193?
The interventions under investigation include: Dexamethasone (DRUG), Fosaprepitant Dimeglumine (DRUG), 5-HT3 antagonist (DRUG).
Who is sponsoring clinical trial NCT04054193?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04054193's enrollment target sits among peer trials
103 760th of 2000 higher than 1,237 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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