Long-term Safety of Minocycline in Patients With Gum Disease

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OraPharma
• Treatments: Minocycline

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