Phase 4
Completed N=35
Long-term Safety of Minocycline in Patients With Gum Disease
Source: ClinicalTrials.gov NCT00668746 ↗Enrolled (actual)
35
Serious AEs
5.7%
Results posted
Mar 2010
Primary outcomePrimary: Change in Percent of Minocycline-Resistant Bacteria Using Bacterial Culture — 13.15; 0.81; 37.65; -2.25 Percentage Change
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Percent of Minocycline-Resistant Bacteria Using Bacterial Culture |
13.15; 0.81; 37.65; -2.25; 8.09; 1.58 | — |
| SECONDARY Micocycline-Resistance From Plaque Samples |
7.14; 1.19; 17.86; 6.82; 6.82; 13.64 | — |
| SECONDARY Micocycline-Resistance From Saliva Sample |
4.76; 0.00; 19.05; 9.09; 9.09; 0.00 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00668746). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.