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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minocycline HCl microspheres | Experimental | Minocycline HCl microspheres |
|
| No drug intervention | No Intervention | No drug intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minocycline HCl microspheres | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percent of Minocycline-Resistant Bacteria Using Bacterial Culture | Percentage Change from Baseline is calculated as post-baseline percent minus baseline percent. | from Baseline to Day 30 and Day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, Day 30 and Day 180 |
| Micocycline-Resistance From Saliva Sample |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Michael Lynch, DMD, PhD | OraPharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forsyth Institute | Boston | Massachusetts | 02115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Minocycline HCl Microspheres | A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm |
| FG001 | No Drug Intervention | A control consisting of no drug intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Minocycline HCl Microspheres | A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm |
| BG001 | No Drug Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Percent of Minocycline-Resistant Bacteria Using Bacterial Culture | Percentage Change from Baseline is calculated as post-baseline percent minus baseline percent. | intention to treat (ITT) | Posted | Mean | Standard Deviation | Percentage Change | from Baseline to Day 30 and Day 180 |
|
180 Days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Minocycline HCl Microspheres | A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SINUSITIS | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ms. Bindu Patel, Senior Scientist, Regulatory Affairs and Quality Assurance | OraPharma | 215-420-4064 | bpatel@orapharma.com |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D008911 | Minocycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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|
Percentage of Subjects Showing Micocycline-Resistance for each Species from Saliva Sample DNA Method: Saliva Sample Intent-to-treat Subjects |
| Baseline, Day 30 and Day 180 |
A control consisting of no drug intervention
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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 | ITT | Posted | Apr 2010 | Number | Percentage of Subjects | Baseline, Day 30 and Day 180 |
|
|
|
| Secondary | 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 | ITT | Posted | Apr 2010 | Number | Percentage of Subjects | Baseline, Day 30 and Day 180 |
|
|
|
| 1 |
| 23 |
| 8 |
| 23 |
| EG001 | No Drug Intervention | A control consisting of no drug intervention | 1 | 12 | 7 | 12 |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| ABSCESS ORAL | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| ORAL DISCOMFORT | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| TOOTHACHE | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| TOOTH FRACTURE | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| TOOTH EXTRACTION | Surgical and medical procedures | MedDRA (12.0) | Systematic Assessment |
|
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| BLOOD GLUCOSE INCREASED | Investigations | MedDRA (12.0) | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| S.constellatus |
|
| E.nodatum |
|
| P.gingivalis |
|
| A.actinomucetemcomitans |
|
| F.nucleatum vincentii |
|
| C.rectus |
|
| R.dentocariosa |
|
| E.saburreum |
|
| P.micra |
|
| V.parvula |
|
| A.oris |
|
| S.anginosus |
|
| S.anguinis |
|
| A.gerencseriae |
|
| S.oralis |
|
| C.ochraccea |
|
| A.israelli |
|
| S.intermedius |
|
| C.matruchotti |
|
| P.nigrescens |
|
| A.odontolyticus |
|
| F.nucleatum polymorphum |
|
| C.showae |
|
| F.periodonticum |
|
| N.mucosa |
|
| F.nucleatum |
|
| C.ginigivaluis |
|
| S.gordonii |
|
| T.forsythia |
|
| S.noxia |
|
| P.acnes |
|
| P.melaninogenica |
|
| S.mitis |
|
| E.corrodens |
|
| G.morbillorum |
|
| C.sputigena |
|
| L.bucallis |
|
| C.gracilis |
|
| P.intermedia |
|
| S.constellatus |
|
| E.nodatum |
|
| P.gingivalis |
|
| A.actinomucetemcomitans |
|
| F.nucleatum vincentii |
|
| C.rectus |
|
| R.dentocariosa |
|
| E.saburreum |
|
| P.micra |
|
| V.parvula |
|
| A.oris |
|
| S.anginosus |
|
| S.anguinis |
|
| A.gerencseriae |
|
| S.oralis |
|
| C.ochraccea |
|
| A.israelli |
|
| S.intermedius |
|
| C.matruchotti |
|
| P.nigrescens |
|
| A.odontolyticus |
|
| F.nucleatum polymorphum |
|
| C.showae |
|
| F.periodonticum |
|
| N.mucosa |
|
| F.nucleatum |
|
| C.ginigivaluis |
|
| S.gordonii |
|
| T.forsythia |
|
| S.noxia |
|
| P.acnes |
|
| P.melaninogenica |
|
| S.mitis |
|
| E.corrodens |
|
| G.morbillorum |
|
| C.sputigena |
|
| L.bucallis |
|
| C.gracilis |
|
| P.intermedia |
|