NCT00687037已完成3 期
Uni Centric Study, Phase III, for Safety Oral Mucosa Evaluation: Basic Acceptability With Odontological Follow up - Cepacol Canela Power
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Patients will be evaluated according to the adverse reactions and the intensity of them. The volunteers will also answer a questionnaire about the physical attributes of the product.
研究概览
简要总结
To prove the safety, in normal conditions, of the odontological use formulation of the product Cepacol Canela Power.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Integral buccal mucous (without oral pathologies);
- •Normal odontological exams;
排除标准
- •Lactation or gestational risk or gestation;
- •Use of Anti-inflammatory or immunosuppression drugs 15 days before the study;
- •Being in odontological treatment;
- •Pathological or mucous disease which can interfere or active gynaecological disease which may interfere wtih study results;
- •Personal history of allergic disease in the area to be treated;
- •Allergic or atopic history;
研究组 & 干预措施
I
Experimental
Cetylpyridinium chloride during 21 days.
干预措施: Cetylpyridinium chloride (Drug)
结局指标
主要结局
Patients will be evaluated according to the adverse reactions and the intensity of them. The volunteers will also answer a questionnaire about the physical attributes of the product.
时间窗: 21 days
次要结局
未报告次要终点
研究者
研究点 (1)
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