NCT01316393已完成4 期
Clinical Evaluation of a Salivary Substitute and a Mucoprotective Product on Xerostomia in Head-and-neck Cancer Patients
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Camurus AB
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- OHIP questionaire health impact profile
研究概览
简要总结
In the present study with a randomized, cross-over, blind, placebo controlled design, the effects of a salivary substitute product and a new mucoprotective product with similar mechanisms of action but with different composition and characteristics will be evaluated in cancer patients suffering from xerostomia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must be at least 18 years of age.
- •The patient must have clinical symptoms of xerostomia (dry mouth) due to treatment of head and neck cancer
- •The patient must understand and consent in writing to the procedure.
排除标准
- •Do not meet the criterion for "dry mouth" regarding saliva secretion threshold values.
- •Known allergy to ingredients in the products to be used in the trial and/or allergy to soy, peanuts, citrus fruit,Yerba Santa or methyl parabene
- •Patients who are unable or unwilling to cooperate with study procedures.
研究组 & 干预措施
XER2020
Experimental
mucoprotective product
干预措施: XER2020 (Other)
Saliva Natura
Active Comparator
salivary substitute
干预措施: XER2020 (Other)
XER2020 placebo
Placebo Comparator
干预措施: XER2020 (Other)
结局指标
主要结局
OHIP questionaire health impact profile
时间窗: 7 days
Effect on oral health quality will be assessed after each treatment period
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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