NCT04503746已完成2 期
A Multi-center, Randomized, Double-Blind, Phase II Clinical Trial to Evaluate the Efficacy and Safety of 12-week Treatment of ALH-L1005 600 mg or 1200 mg in Patients With Chronic Periodontitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Change in Pocket Depth(PD)
研究概览
简要总结
The main objective of this study is to evaluate efficacy and safety of ALH-L1005 in patients with chronic periodontitis
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women ages 18 and over, under 79 years of age
- •Patients diagnosed with chronic periodontitis
- •Patients with 4 teeth and over whose pocket depth is ≥ 4 mm and clinical attachment level is ≥ 3 mm
- •Patients who are voluntarily participated in clinical trial
排除标准
- •History of antibiotic therapy within the 1 month prior to study
- •Those who had undergone any dental surgical or non-surgical therapy within 3 months prior to the start of the study
- •Subjects who are pregnant/ lactating
- •Patients who take Anticoagulants or Antiplatelet Agents
- •With Systemic diseases that affect periodontal conditions such as: diabetes, hypertension and diseases of immune system
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo twice a day
干预措施: Placebo (Drug)
ALH-L1005 600 mg
Experimental
ALH-L1005 300 mg twice a day
干预措施: ALH-L1005 600mg/day (Drug)
ALH-L1005 1,200 mg
Experimental
ALH-L1005 600 mg twice a day
干预措施: ALH-L1005 1,200mg/day (Drug)
结局指标
主要结局
Change in Pocket Depth(PD)
时间窗: baseline, 12 weeks
Change in Pocket Depth in Subjects
次要结局
- Change in Gingival recession(GR)(baseline, 12 weeks)
- Change in Bleeding on probing(BOP) score(baseline, 12 weeks)
- Change in Pocket Depth(PD)(baseline, 4 weeks, 8 weeks)
- Change in Clinical Attachment Level(CAL)(baseline, 4 weeks, 8 weeks, 12 weeks)
研究者
研究点 (1)
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