Long-term Safety of Minocycline in Patients With Gum Disease

OraPharma

Status and phase

Completed

Phase 4

Conditions

Periodontitis

Treatments

Drug: Minocycline HCl microspheres

Study type

Interventional

Funder types

Industry

Identifiers

NCT00668746

OP-P-5756-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

35 patients

Sex

All

Ages

25+ years old

Volunteers

No Healthy Volunteers

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