Clinical trial NCT00668746: Long-term Safety of Minocycline in Patients With Gum Disease
Official title: Long-term Safety Evaluation of Minocycline Resistance After Treatment With Minocycline HCl Microspheres, 1 mg in Subjects With Chronic Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Periodontitis
Keywords: chronic periodontitis, antibiotic resistance
Lead sponsor: OraPharma
Sponsor class: INDUSTRY
First posted: 2008-04-29
Enrollment: 35
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 for a long time.

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 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.

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

Primary outcomes:
measure: Change in Percent of Minocycline-Resistant Bacteria Using Bacterial Culture
timeFrame: from Baseline to Day 30 and Day 180
Secondary outcomes:
measure: Micocycline-Resistance From Plaque Samples
timeFrame: Baseline, Day 30 and Day 180
measure: Micocycline-Resistance From Saliva Sample
timeFrame: Baseline, Day 30 and Day 180
Other outcomes:
Locations:
city: Boston
country: United States
facility: Forsyth Institute
state: Massachusetts
Study officials:
affiliation: OraPharma
name: Michael Lynch, DMD, PhD
role: STUDY_DIRECTOR
References: