A Clinical Trial of YH14642 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 YH14642 in Korea patients with chronic periodontitis, in order to investigate the recommended therapeutic dose.

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 YH14642 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: YH14642 500mg Tab
* Drug: YH14642 500mg Tab
* Drug: YH14642 500mg Tab
* Drug: INSADOL[Zea mays L. extract] 35mg Tab
* Drug: DENTISTA[Doxycycline hyclate] 20mg Cap
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be 20 years of age or older Have at least 18 natural teeth Four or more clinical attachment level(CAL) ≥ 3mm Four or more periodontal pockets with a probing depth (PD) ≥ 4mm Have Bleeding on probing Provide informed consent and willingness to cooperate with the study protocol Exclusion Criteria: Forbidden History of Panax Notoginseng and Rehmanniae Radix Preparata Hypersensitivity of Doxycycline Hypersensitivity of Zea mays L. extract Critical diseases such as HIV previous three years Patients with mental retardation and dementia Systemic diseases such as diabetes and hypertension Patients who take Anticoagulants or Antiplatelet Agents Patients who have malignant tumor Smoker Continually use for 2weeks of phenytoin, calcium channel blocker, cyclosporin, coumarin, nonsteroidal anti-inflammatory drugs and aspirin use in the previous one month Patients who need malignant tumor Patients who received periodontal treatment within the last 6 months Pregnant or lactating females

Ages Eligible for Study
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Minimum Age: 20 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: YH14642 A-I<br> | Drug: YH14642 500mg Tab<br>* YH14642 500mg per day(once a day)<br>|
| Experimental: YH14642 A-II<br> | Drug: YH14642 500mg Tab<br>* YH14642 1000mg per day(twice a day)<br>|
| Experimental: YH14642 A-III<br> | Drug: YH14642 500mg Tab<br>* YH14642 2000mg per day(three times a day)<br>|
| Active Comparator: Active Comparator B<br> | Drug: INSADOL[Zea mays L. extract] 35mg Tab<br>* [Initiation dose : 4weeks after administraion] INSADOL[Zea mays L. extract] 210mg TAB per day [Maintain dose : Between 4weeks and 8weeks after administraion] INSADOL[Zea mays L. extract] 105mg TAB per day [Maintain dose : Between 8weeks and 12weeks after administraion] INSADOL[Zea mays L. extract] 105mg TAB per day<br>|
| Active Comparator: Active Comparator C<br> | Drug: DENTISTA[Doxycycline hyclate] 20mg Cap<br>* DENTISTA[Doxycycline hyclate] Cap 40mg per day<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 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, 8weeks and 12weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinical attachment level (CAL) |  | baseline, 4weeks, 8weeks and 12weeks | 
| Change in Bleeding on probing(BOP) |  | baseline, 4weeks, 8weeks and 12weeks | 
| change in Gingival index(GI) |  | baseline, 4weeks, 8weeks and 12weeks | 
| Change in Plaque index (PI) |  | baseline, 4weeks, 8weeks and 12weeks | 
| Change in Gingival recession(GR) |  | baseline, 4weeks, 8weeks and 12weeks | 
| [Exploratory Outcome Measure] Change in Alveolar bone height(ABH) |  | baseline and 12weeks | 
| [Exploratory Outcome Measure] Change in Alveolar bone density(ABD) |  | baseline and 12weeks |