Status:
COMPLETED
Long-term Safety of Minocycline in Patients With Gum Disease
Lead Sponsor:
OraPharma
Conditions:
Periodontitis
Eligibility:
All Genders
25+ years
Phase:
PHASE4
Brief 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 f...
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 ch...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00668746
Start Date
December 1 2007
End Date
February 1 2009
Last Update
December 12 2011
Active Locations (1)
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1
Forsyth Institute
Boston, Massachusetts, United States, 02115