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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-16

Study Completion Date

2017-06-27

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.

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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).

Conditions

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Chronic Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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YH23537 1000mg/day

YH23537 500mg 2 tab

Intervention Type DRUG

YH23537 2000mg/day

YH23537 500mg 4 tab

Intervention Type DRUG

YH23537 3000mg/day

YH23537 500mg 6 tab

Intervention Type DRUG

placebo

YH23537 500mg tab placebo

Intervention Type DRUG

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No