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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 is a Phase 4 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 103 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04054193
The ClinicalTrials.gov registry entry for NCT04054193 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.
NCT04054193 reports 0 study locations.
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.
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