NCT01499225已完成2 期
A Double-blind, Randomized, Parallel, Placebo-active Controlled, Multi-center Phase II Clinical Trial to Investigate the Efficacy and Safety of YH14642 Following 12-week Oral Administration in Patients With Chronic Periodontal Disease
Yuhan Corporation1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2011年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 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 YH14642 in Korea patients with chronic periodontitis, in order to investigate the recommended therapeutic dose.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be 20 years of age or older
- •Have at least 18 natural teeth
- •Four or more clinical attachment level(CAL) ≥ 3mm
- •Four or more periodontal pockets with a probing depth (PD) ≥ 4mm
- •Have Bleeding on probing
- •Provide informed consent and willingness to cooperate with the study protocol
排除标准
- •Forbidden History of Panax Notoginseng and Rehmanniae Radix Preparata
- •Hypersensitivity of Doxycycline
- •Hypersensitivity of Zea mays L. extract
- •Critical diseases such as HIV previous three years
- •Patients with mental retardation and dementia
- •Systemic diseases such as diabetes and hypertension
- •Patients who take Anticoagulants or Antiplatelet Agents
- •Patients who have malignant tumor
- •Continually use for 2weeks of phenytoin, calcium channel blocker, cyclosporin, coumarin, nonsteroidal anti-inflammatory drugs and aspirin use in the previous one month
- •Patients who need malignant tumor
- •Patients who received periodontal treatment within the last 6 months
- •Pregnant or lactating females
研究组 & 干预措施
YH14642 A-I
Experimental
干预措施: YH14642 500mg Tab (Drug)
YH14642 A-II
Experimental
干预措施: YH14642 500mg Tab (Drug)
YH14642 A-III
Experimental
干预措施: YH14642 500mg Tab (Drug)
Active Comparator B
Active Comparator
干预措施: INSADOL[Zea mays L. extract] 35mg Tab (Drug)
Active Comparator C
Active Comparator
干预措施: DENTISTA[Doxycycline hyclate] 20mg Cap (Drug)
Placebo
Placebo Comparator
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, 8weeks and 12weeks
次要结局
- Change in Clinical attachment level (CAL)(baseline, 4weeks, 8weeks and 12weeks)
- Change in Bleeding on probing(BOP)(baseline, 4weeks, 8weeks and 12weeks)
- change in Gingival index(GI)(baseline, 4weeks, 8weeks and 12weeks)
- [Exploratory Outcome Measure] Change in Alveolar bone density(ABD)(baseline and 12weeks)
- Change in Gingival recession(GR)(baseline, 4weeks, 8weeks and 12weeks)
- [Exploratory Outcome Measure] Change in Alveolar bone height(ABH)(baseline and 12weeks)
- Change in Plaque index (PI)(baseline, 4weeks, 8weeks and 12weeks)
研究者
研究点 (1)
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