Long-term Safety of Minocycline in Patients With Gum Disease

Phase 4

Completed

• Conditions: Periodontitis
• Interventions: Drug: Minocycline HCl microspheres

• Registration Number: NCT00668746
• Lead Sponsor: OraPharma

Brief 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.

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-04-24
• Study First Submitted QC: 2008-04-24
• Study First Posted: 2008-04-29
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Results First Submitted: 2010-02-26
• Results First Submitted QC: 2010-02-26
• Results First Posted: 2010-03-16
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-06
• Last Update Posted: 2011-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• generally healthy
• over 25 years of age
• moderate-to-severe chronic periodontitis
• documented informed consent
• willing to comply with contraceptive requirements
• free from any significant oral soft tissue pathology

Exclusion Criteria

• willing to adhere to prohibitions and restrictions of the study

• oral health inappropriate for study inclusion

• females self-reporting pregnancy or lactation, or having a positive urine pregnancy result

• reporting any of the following conditions:

  • allergy to a tetracycline-class drug
  • systemic medical conditions requiring antibiotic prophylaxis prior to invasive dental procedures
  • active systemic infectious disease such as hepatitis, human immunodeficiency virus (HIV) or tuberculosis
  • diagnosed with clinically significant or unstable organic disease, or compromised healing potential, heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement

• participation in a dental clinical trial or use of an investigational drug within 30 days of enrollment

• employees of the Investigator or study center, with direct involvement in the proposed study or other studies, as well as family members of the employees or the Investigator

• anyone who the investigator determines should not be included in the study for any reason that could compromise safety or the analysis of study results

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Minocycline HCl microspheres	Minocycline HCl microspheres	Minocycline HCl microspheres

Primary Outcome Measures

Name	Time	Method
Change in Percent of Minocycline-Resistant Bacteria Using Bacterial Culture	from Baseline to Day 30 and Day 180	Percentage Change from Baseline is calculated as post-baseline percent minus baseline percent.

Secondary Outcome Measures

Name	Time	Method
Micocycline-Resistance From Plaque Samples	Baseline, Day 30 and Day 180	Percentage of Subjects showing Micocycline-Resistance for each Species from Plaque Samples DNA Method: Plaque Sample Intent-to-Treat Subjects - we report average of percentage for 4 plaque samples
Micocycline-Resistance From Saliva Sample	Baseline, Day 30 and Day 180	Percentage of Subjects Showing Micocycline-Resistance for each Species from Saliva Sample DNA Method: Saliva Sample Intent-to-treat Subjects

Trial Locations

Locations (1)

Forsyth Institute; 🇺🇸 Boston, Massachusetts, United States