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

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Drug: Minocycline HCl microspheres

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Forsyth Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Minocycline HCl microspheres	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.; Other Names: minocycline
NO_INTERVENTION: No drug intervention

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Micocycline-Resistance From Plaque Samples	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	Baseline, Day 30 and Day 180
Micocycline-Resistance From Saliva Sample	Percentage of Subjects Showing Micocycline-Resistance for each Species from Saliva Sample DNA Method: Saliva Sample Intent-to-treat Subjects	Baseline, Day 30 and Day 180

Collaborators and Investigators

• Sponsor: OraPharma
• Investigators: Study Director: Michael Lynch, DMD, PhD, OraPharma

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (ACTUAL): February 1, 2009
• Study Completion (ACTUAL): February 1, 2009

Study Registration Dates

• First Submitted: April 24, 2008
• First Submitted That Met QC Criteria: April 24, 2008
• First Posted (ESTIMATE): April 29, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): December 12, 2011
• Last Update Submitted That Met QC Criteria: December 6, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: chronic periodontitis, antibiotic resistance
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Anti-Infective Agents; Anti-Bacterial Agents; Minocycline
• Other Study ID Numbers: OP-P-5756-1