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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 is a Phase 3 study that has completed, run by OraPharma. The registered enrollment target is 215 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01539564
The ClinicalTrials.gov registry entry for NCT01539564 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 215 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OraPharma, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Minocycline HCl Microspheres is the first listed.
NCT01539564 reports 0 study locations.
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.
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