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NCT01539564 · ClinicalTrials.gov registry record · Phase 3
Arestin - Use in Subjects With Peri-Implantitis
A Phase 3 study, sponsored by OraPharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 215
- Enrollment target
NCT01539564: Completed Phase 3 study, sponsored by OraPharma.
NCT01539564 is a Phase 3 study that has completed, run by OraPharma. The registered enrollment target is 215 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01539564, a Phase 3 study, has completed, sponsored by OraPharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 215 participants
- Enrollment target
Study Summary
The objective of the study is to evaluate the safety and effectiveness of Arestin (minocycline HCl) 1 mg Microspheres in the treatment of subjects with peri-implantitis, when used in combination with mechanical debridement. The hypothesis of the study is that Arestin in combination with mechanical debridement is more effective in the treatment of peri-implantitis when compared to mechanical debridement alone. The primary efficacy measure will be the reduction of probing depth at Day 180 as measured at qualifying implant sites.
Interventions
- DRUG Minocycline HCl Microspheres
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2012-04 |
| Est. Completion | 2014-06 |
| Phase | Phase 3 |
What the finished NCT01539564 record still lists
NCT01539564 is an interventional study that assigns participants to a tested intervention. The registered 215 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which Minocycline HCl Microspheres is the first listed.
NCT01539564 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01539564 about?
NCT01539564 is a clinical study titled "Arestin - Use in Subjects With Peri-Implantitis". The objective of the study is to evaluate the safety and effectiveness of Arestin (minocycline HCl) 1 mg Microspheres in the treatment of subjects with peri-implantitis, when used in combination with mechanical debridement. The hypothesis of the study is that Arestin in combination with mechanical ...
What is the current status of trial NCT01539564?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 215 participants. The study started on 2012-04. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01539564?
The interventions under investigation include: Minocycline HCl Microspheres (DRUG).
Who is sponsoring clinical trial NCT01539564?
This trial is sponsored by OraPharma, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01539564's enrollment target sits among peer trials
215 1334th of 2000 higher than 666 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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