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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02585596

Enrollment

275

Registered

2015-10-23

Start date

2015-12-16

Completion date

2017-06-27

Last updated

2019-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Periodontitis

Brief summary

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

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).

Interventions

DRUGYH23537 1000mg/day

YH23537 500mg 2 tab

DRUGYH23537 2000mg/day

YH23537 500mg 4 tab

DRUGYH23537 3000mg/day

YH23537 500mg 6 tab

DRUGplacebo

YH23537 500mg tab placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in probing pocket depth (PD)	baseline, 4weeks, 8week, 12weeks

Secondary

Measure	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026