NCT00668746

Long-term Safety of Minocycline in Patients With Gum Disease

Long-term Safety Evaluation of Minocycline Resistance After Treatment With Minocycline HCl Microspheres, 1 mg in Subjects With Chronic Periodontitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: OraPharma · Industry
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The objective of this study is to evaluate the changes in populations of minocycline-resistant bacteria after long-term use of minocycline HCl microspheres, 1 mg in subjects with moderate-to-severe chronic periodontitis. This will be assessed through monitoring the total number and proportion of minocycline-resistant bacteria and the identity of minocycline-resistant species within a panel of 40 representative periodontal species in saliva and subgingival plaque.

Conditions

• Periodontitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-04-29
• Last updated: 2011-12-12
• Results posted: 2010-03-16

Locations

1 site across 1 country: United States