A Phase II Clinical Trial of YH23537 in Patients With Chronic Periodontal Disease.

Study Overview
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Brief Summary
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This study is designed to evaluate the efficacy and the safety of YH23537 in Korea patients with chronic periodontitis, in order to investigate the recommended therapeutic dose.

Detailed Description
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at screening visit, at least existing 18 teeth,Mild/moderate/severe periodontitis patients diagnosed with chronic periodontitis according to the CDC / AAP (Center for Disease Control / American Academy for Periodontology) periodontitis classification (2012).

Official Title
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A Double-blind, Randomized, Parallel, Placebo-active Controlled, Multi-center Phase II Clinical Trial to Investigate the Efficacy and Safety of YH23537 Following 12-week Oral Administration in Patients With Chronic Periodontal Disease

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Drug: YH23537 1000mg/day
* Drug: YH23537 2000mg/day
* Drug: YH23537 3000mg/day
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be 19 years of age or older Have at least 18 natural teeth have been diagnosed with chronic periodontitis have been diagnosed Mild/Moderate/Severe periodontitis with according to CDC / AAP periodontal classification (2012)) Provide informed consent and willingness to cooperate with the study protocol Exclusion Criteria: Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study and for up to 4 weeks after the last dose of investigational product. Pregnant or lactating females Systemic diseases such as diabetes and hypertension Patients who take Anticoagulants or Antiplatelet Agents Continually use for phenytoin, calcium channel blocker, cyclosporin, coumarin, nonsteroidal anti-inflammatory drugs and aspirin use in the previous one month Patients who received periodontal treatment within the last 6 months Patients who have malignant tumor History of positive serologic evidence of current infectious liver disease including HbsAg, or anti-HCV. Patients with mental retardation and dementia

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YH23537 1000mg/day<br>YH23537 500mg 1 tab, placebo 500mg 2tab twice a day (before morning,evening meal) during 12 weeks | Drug: YH23537 1000mg/day<br>* YH23537 500mg 2 tab<br>Drug: placebo<br>* YH23537 500mg tab placebo<br>|
| Experimental: YH23537 2000mg/day<br>YH23537 500mg 2tab, placebo 500mg 1tab twice day (before morning,evening meal) during 12 weeks | Drug: YH23537 2000mg/day<br>* YH23537 500mg 4 tab<br>Drug: placebo<br>* YH23537 500mg tab placebo<br>|
| Experimental: YH23537 3000mg/day<br>YH23537 500mg 3tab a day twice day (before morning,evening meal) during 12 weeks | Drug: YH23537 3000mg/day<br>* YH23537 500mg 6 tab<br>|
| Experimental: YH23537 3000mg/day loading 1000mg/day<br>YH23537 500mg 3tab twice a day (before morning,evening meal) during 4weeks and YH23537 500mg tab twice a day (before morning,evening meal) during 8weeks | Drug: YH23537 1000mg/day<br>* YH23537 500mg 2 tab<br>Drug: YH23537 3000mg/day<br>* YH23537 500mg 6 tab<br>Drug: placebo<br>* YH23537 500mg tab placebo<br>|
| Placebo Comparator: Placebo<br>YH23537 500mg placebo 3tab twice a day | Drug: placebo<br>* YH23537 500mg tab placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in probing pocket depth (PD) |  | baseline, 4weeks, 8week, 12weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinical attachment level (CAL) |  | baseline, 4weeks, 8week, 12weeks | 
| Change in Bleeding on probing(BOP) |  | baseline, 4weeks, 8week, 12weeks | 
| Change in Gingival recession(GR) |  | baseline, 4weeks, 8week, 12weeks |