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NCT04186663 · ClinicalTrials.gov registry record · Phase 2
Pharmacokinetics of Advantage Arrest in Children
A Phase 2 study, sponsored by Advantage Silver Dental Arrest.
- Completed
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
NCT04186663: Completed Phase 2 study, sponsored by Advantage Silver Dental Arrest.
NCT04186663 is a Phase 2 study that has completed, run by Advantage Silver Dental Arrest. The registered enrollment target is 59 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04186663, a Phase 2 study, has completed, sponsored by Advantage Silver Dental Arrest.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
Study Summary
The purpose of this study is to characterize basic PK parameters (Cmax, t1/2, AUC) in healthy children to contribute to evidence for the safety of Advantage Arrest, consistent with Guidance for Industry--Exposure--Response Relationships (April 2003).
Primary Outcome
As only a single blood sample was obtained from each child, serum silver concentration versus time data were analyzed simultaneously using population pharmacokinetic analysis with nonlinear mixed effects modeling. The parameters estimated were the apparent volume of distribution (V/F) and apparent oral clearance (CL/F). The rate constant of absorption (ka) was fixed to 23.7 day-1. The predicted peak serum silver Cmax was calculated using Cmax = Dose/(V/F)\*exp\^(-k⋅tmax ), where k = (CL/F)/(V/F)
Interventions
- DRUG Silver Diamine Fluoride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2019-08-01 |
| Est. Completion | 2020-03-31 |
| Phase | Phase 2 |
What the finished NCT04186663 record still lists
NCT04186663 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 1 intervention - of which Silver Diamine Fluoride is the first listed.
NCT04186663 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04186663 about?
NCT04186663 is a clinical study titled "Pharmacokinetics of Advantage Arrest in Children". The purpose of this study is to characterize basic PK parameters (Cmax, t1/2, AUC) in healthy children to contribute to evidence for the safety of Advantage Arrest, consistent with Guidance for Industry--Exposure--Response Relationships (April 2003).
What is the current status of trial NCT04186663?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2019-08-01. Estimated completion is 2020-03-31.
What interventions are being tested in trial NCT04186663?
The interventions under investigation include: Silver Diamine Fluoride (DRUG).
Who is sponsoring clinical trial NCT04186663?
This trial is sponsored by Advantage Silver Dental Arrest, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04186663's enrollment target sits among peer trials
59 1133rd of 2000 higher than 866 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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