Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Safety Study

Study Primary Completion Date: December 2009

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Minocycline HCl microspheres
• No Intervention: 2
  • No drug intervention

Primary Measures

• Change in the proportion (percent) of minocycline-resistant bacteria (as measured by bacterial culture) for whole, unstimulated saliva and subgingival plaque
  • Time Frame: from Baseline to Day 730 +/- 60 days
    Safety Issue?: No

Secondary Measures

• Changes in the proportion (percent) of minocycline-resistant bacteria for saliva and subgingival plaque and total number of minocycline-resistant bacteria
  • Time Frame: from Baseline to all other time points (i.e., Days 30 to 635)
    Safety Issue?: No
• Identification of minocycline-resistant species within a panel of 40 representative periodontal species
  • Time Frame: from baseline to all other time points through Day 730
    Safety Issue?: No
• Safety assessments will consist of monitoring and recording all nonserious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to study drug
  • Time Frame: throughout duration of the study (+ 30 days for spontaneous SAEs)
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 25 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Johnson & Johnson Consumer & Personal Products Worldwide

Overall Clinical Trial Officials and Contacts

Michael Lynch, DMD, PhD Study Director OraPharma  

Overall Contact: Joyce L Hauze, MBA, CCRA 973-385-6104 jhauze@its.jnj.com

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00668746

Study ID Number: OP-P-5756-1

ClinicalTrials.gov Identifier: NCT00668746

Health Authority: United States: Institutional Review Board