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Long-term Safety of Minocycline in Patients With Gum Disease

NCT00668746 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2011-12-12

Study results available
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Summary

This study will look at the safety of using the study medicine for a long time. It will see if the germs get used to the medicine, making it not work as well, if it's used by people with gum disease for a long time.

Conditions

  • Periodontitis

Interventions

DRUG

Minocycline HCl microspheres

At Baseline and all interim visits, a single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) will be professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm.

Sponsors & Collaborators

  • OraPharma

    lead INDUSTRY

Principal Investigators

  • Michael Lynch, DMD, PhD · OraPharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00668746 on ClinicalTrials.gov