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

• Status: Completed
• Trial end date: 2017-06-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuhan Corporation

Criteria

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