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NCT01591616 · ClinicalTrials.gov registry record · Phase 4
Pediatric Study to Access Pharmacokinetics and Safety of Oraqix Gel
A Phase 4 study, sponsored by Dentsply International.
- Completed
- Registry status
- Phase 4
- Development phase
- 16
- Enrollment target
NCT01591616: Completed Phase 4 study, sponsored by Dentsply International.
NCT01591616 is a Phase 4 study that has completed, run by Dentsply International. The registered enrollment target is 16 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01591616, a Phase 4 study, has completed, sponsored by Dentsply International.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 16 participants
- Enrollment target
Study Summary
To establish Oraqix is safe when used on adolescent volunteers.
Primary Outcome
The study focused on the pharmacokinetics of prilocaine and lidocaine, o-toluidine (metabolite of prilocaine) and 2, 6-xylidine (metabolite of lidocaine). We evaluated blood samples of15 subjects at the following time points: pre-dose, at 5,10,15,30, 60, 90, 120 and 240 min post dose. We calculated Cmax (maximum observed plasma concentration) and Tmax (time to maximum plasma concentration).
Interventions
- DRUG lidocaine and prilocaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2010-04 |
| Est. Completion | 2012-04 |
| Phase | Phase 4 |
What the finished NCT01591616 record still lists
NCT01591616 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which lidocaine and prilocaine is the first listed.
NCT01591616 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01591616 about?
NCT01591616 is a clinical study titled "Pediatric Study to Access Pharmacokinetics and Safety of Oraqix Gel". To establish Oraqix is safe when used on adolescent volunteers.
What is the current status of trial NCT01591616?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2010-04. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01591616?
The interventions under investigation include: lidocaine and prilocaine (DRUG).
Who is sponsoring clinical trial NCT01591616?
This trial is sponsored by Dentsply International, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01591616's enrollment target sits among peer trials
16 1869th of 2000 higher than 121 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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