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

Yuhan

Status and phase: Completed; Phase 2

Conditions: Chronic Periodontitis

Treatments: Drug: YH23537 2000mg/day; Drug: YH23537 3000mg/day; Drug: YH23537 1000mg/day; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02585596

YH23537-201

Details and patient eligibility

About

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.

Full 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).

Enrollment: 275 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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275 participants in 5 patient groups, including a placebo group

YH23537 1000mg/day

Experimental group

Description:

YH23537 500mg 1 tab, placebo 500mg 2tab twice a day (before morning,evening meal) during 12 weeks

Treatment:

Drug: placebo

Drug: YH23537 1000mg/day

YH23537 2000mg/day

Experimental group

Description:

YH23537 500mg 2tab, placebo 500mg 1tab twice day (before morning,evening meal) during 12 weeks

Treatment:

Drug: placebo

Drug: YH23537 2000mg/day

YH23537 3000mg/day

Experimental group

Description:

YH23537 500mg 3tab a day twice day (before morning,evening meal) during 12 weeks

Treatment:

Drug: YH23537 3000mg/day

YH23537 3000mg/day loading 1000mg/day

Experimental group

Description:

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

Treatment:

Drug: placebo

Drug: YH23537 1000mg/day

Drug: YH23537 3000mg/day

Placebo

Placebo Comparator group

Description:

YH23537 500mg placebo 3tab twice a day

Treatment:

Drug: placebo