Long-term Safety of Minocycline in Patients With Gum Disease

Completed · Phase 4

Conditions studied: Periodontitis

In brief

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.

Key facts

Study ID

NCT00668746

Run by

OraPharma

People needed

35

Starts

2007-12-01

Expected to finish

2009-02-01

Last updated by the study team

2011-12-12

Who can join

Age: 25 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Forsyth Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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