Long-Term Safety of Minocycline in Patients With Gum Disease

Condition(s) targeted: Periodontitis

Intervention: Minocycline HCl microspheres (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Johnson & Johnson Consumer & Personal Products Worldwide

Official(s) and/or principal investigator(s):
Michael Lynch, DMD, PhD, Study Director, Affiliation: OraPharma

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

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.

Official title: Long-Term Safety Evaluation of Minocycline Resistance After Treatment With Minocycline HCl Microspheres, 1 mg in Subjects With Chronic Periodontitis

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

Primary outcome: Change in the proportion (percent) of minocycline-resistant bacteria (as measured by bacterial culture) for whole, unstimulated saliva and subgingival plaque

Secondary outcome:

Changes in the proportion (percent) of minocycline-resistant bacteria for saliva and subgingival plaque and total number of minocycline-resistant bacteria

Identification of minocycline-resistant species within a panel of 40 representative periodontal species

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

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.

Minimum age: 25 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

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

Forsyth Institute, Boston, Massachusetts 02115, United States; Recruiting
Ricardo P Teles, DDS, DMSc, Principal Investigator

Starting date: December 2007
Ending date: January 2010
Last updated: September 24, 2008