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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 275
- 试验地点
- 1
- 主要终点
- Change in probing pocket depth (PD)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
YH23537 3000mg/day
YH23537 500mg 3tab a day twice day (before morning,evening meal) during 12 weeks
干预措施: YH23537 3000mg/day (Drug)
YH23537 1000mg/day
YH23537 500mg 1 tab, placebo 500mg 2tab twice a day (before morning,evening meal) during 12 weeks
干预措施: YH23537 1000mg/day (Drug)
YH23537 1000mg/day
YH23537 500mg 1 tab, placebo 500mg 2tab twice a day (before morning,evening meal) during 12 weeks
干预措施: placebo (Drug)
YH23537 2000mg/day
YH23537 500mg 2tab, placebo 500mg 1tab twice day (before morning,evening meal) during 12 weeks
干预措施: YH23537 2000mg/day (Drug)
YH23537 2000mg/day
YH23537 500mg 2tab, placebo 500mg 1tab twice day (before morning,evening meal) during 12 weeks
干预措施: placebo (Drug)
YH23537 3000mg/day loading 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
干预措施: YH23537 1000mg/day (Drug)
YH23537 3000mg/day loading 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
干预措施: YH23537 3000mg/day (Drug)
YH23537 3000mg/day loading 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
干预措施: placebo (Drug)
Placebo
YH23537 500mg placebo 3tab twice a day
干预措施: placebo (Drug)
结局指标
主要结局
Change in probing pocket depth (PD)
时间窗: baseline, 4weeks, 8week, 12weeks
次要结局
- 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)