A Phase II Clinical Trial of YH23537 in Patients With Chronic Periodontal Disease.
Phase 2
Completed
- Conditions
- Chronic Periodontitis
- Interventions
- Drug: YH23537 1000mg/dayDrug: YH23537 2000mg/dayDrug: YH23537 3000mg/dayDrug: placebo
- Registration Number
- NCT02585596
- Lead Sponsor
- Yuhan Corporation
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 275
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description YH23537 1000mg/day YH23537 1000mg/day YH23537 500mg 1 tab, placebo 500mg 2tab twice a day (before morning,evening meal) during 12 weeks YH23537 2000mg/day YH23537 2000mg/day YH23537 500mg 2tab, placebo 500mg 1tab twice day (before morning,evening meal) during 12 weeks YH23537 3000mg/day loading 1000mg/day YH23537 1000mg/day 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 YH23537 1000mg/day placebo YH23537 500mg 1 tab, placebo 500mg 2tab twice a day (before morning,evening meal) during 12 weeks YH23537 2000mg/day placebo YH23537 500mg 2tab, placebo 500mg 1tab twice day (before morning,evening meal) during 12 weeks YH23537 3000mg/day loading 1000mg/day placebo 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 YH23537 3000mg/day YH23537 3000mg/day YH23537 500mg 3tab a day twice day (before morning,evening meal) during 12 weeks YH23537 3000mg/day loading 1000mg/day YH23537 3000mg/day 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 Placebo placebo YH23537 500mg placebo 3tab twice a day
- Primary Outcome Measures
Name Time Method Change in probing pocket depth (PD) baseline, 4weeks, 8week, 12weeks
- Secondary Outcome Measures
Name Time Method Change in Bleeding on probing(BOP) baseline, 4weeks, 8week, 12weeks Change in Clinical attachment level (CAL) baseline, 4weeks, 8week, 12weeks Change in Gingival recession(GR) baseline, 4weeks, 8week, 12weeks
Trial Locations
- Locations (1)
Incheol Rhyu
🇰🇷Seoul, Korea, Republic of