Back to resultsLong-term Safety of Minocycline in Patients With Gum Disease
Primary Purpose
Periodontitis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Minocycline HCl microspheres
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis focused on measuring chronic periodontitis, antibiotic resistance
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
Sites / Locations
- Forsyth Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Minocycline HCl microspheres
No drug intervention
Arm Description
Minocycline HCl microspheres
No drug intervention
Outcomes
Primary Outcome Measures
Change in Percent of Minocycline-Resistant Bacteria Using Bacterial Culture
Percentage Change from Baseline is calculated as post-baseline percent minus baseline percent.
Secondary Outcome Measures
Micocycline-Resistance From Plaque Samples
Percentage of Subjects showing Micocycline-Resistance for each Species from Plaque Samples DNA Method: Plaque Sample Intent-to-Treat Subjects - we report average of percentage for 4 plaque samples
Micocycline-Resistance From Saliva Sample
Percentage of Subjects Showing Micocycline-Resistance for each Species from Saliva Sample DNA Method: Saliva Sample Intent-to-treat Subjects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00668746
Brief Title
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
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OraPharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
chronic periodontitis, antibiotic resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Minocycline HCl microspheres
Arm Type
Experimental
Arm Description
Minocycline HCl microspheres
Arm Title
No drug intervention
Arm Type
No Intervention
Arm Description
No drug intervention
Intervention Type
Drug
Intervention Name(s)
Minocycline HCl microspheres
Other Intervention Name(s)
minocycline
Intervention Description
At Baseline and all interim visits, a single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) will be professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm.
Primary Outcome Measure Information:
Title
Change in Percent of Minocycline-Resistant Bacteria Using Bacterial Culture
Description
Percentage Change from Baseline is calculated as post-baseline percent minus baseline percent.
Time Frame
from Baseline to Day 30 and Day 180
Secondary Outcome Measure Information:
Title
Micocycline-Resistance From Plaque Samples
Description
Percentage of Subjects showing Micocycline-Resistance for each Species from Plaque Samples DNA Method: Plaque Sample Intent-to-Treat Subjects - we report average of percentage for 4 plaque samples
Time Frame
Baseline, Day 30 and Day 180
Title
Micocycline-Resistance From Saliva Sample
Description
Percentage of Subjects Showing Micocycline-Resistance for each Species from Saliva Sample DNA Method: Saliva Sample Intent-to-treat Subjects
Time Frame
Baseline, Day 30 and Day 180
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Lynch, DMD, PhD
Organizational Affiliation
OraPharma
Official's Role
Study Director
Facility Information:
Facility Name
Forsyth Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Long-term Safety of Minocycline in Patients With Gum Disease
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