Study of the Effect and Safety of Three New Oral Sprays and a Reference Marketed Oral Spray in the Relief of Drug-induced Xerostomia Associated With Hyposialia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Observed area under the curve of dry mouth evaluations
研究概览
简要总结
The purpose of this study is to evaluate the clinical efficacy, the safety and acceptability of three new oral sprays with a reference oral spray in the relief of drug-induced xerostomia associated with hyposialia, i.e. dryness of the mouth induced by a decrease of salivation (hyposialia) induced by chronic drug intake.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects,
- •Adult subjects (≥18 years) taking drug(s) causing salivary hypofunction / xerostomia, for at least 1 week prior to study initiation and expected to continue without change during study
- •Subjects with a complaint of dry mouth as assessed by a response of 40mm or greater on item "Rate the dryness of your mouth" of the Dry Mouth Visual Analogue Scale (VAS) questions. (The VAS limits will be 0 representing normal [i.e. no dry mouth symptoms] and 100 representing "the worst imaginable" dry mouth symptoms). This score should also be met before the 1st product application, on P1 D
- •Documented hyposalivation with test of resting saliva weight absorbed ≤ 0.5g/5 min at baseline
排除标准
- •Presence of disorders (bucco-dental disease, history of major medical/psychiatric illness or surgery, ... ) which, in the judgement of the investigator, may interfere with study implementation and/or study parameter assessment(s).
- •Sjögren syndrome and related autoimmune diseases,
- •Other medical causes of xerostomia (oral candidiasis).
- •History of head and neck irradiation and cancer chemotherapy
- •History of hypersensitivity to any of the components of the investigational products,
- •History or current excessive use of alcohol,
- •History of drug addiction,
- •Presence of treatments for their dry mouth within 7 days prior to inclusion into the study
研究组 & 干预措施
cross-over
Four periods separated by a wash out lasting up to 3 days at maximum. At each period, application of one product (twice). Duration of treatment period: From 4 to 13 days.
干预措施: Tested product : DC161-DP0291 (Device)
cross-over
Four periods separated by a wash out lasting up to 3 days at maximum. At each period, application of one product (twice). Duration of treatment period: From 4 to 13 days.
干预措施: Tested product : DC161-DP0292 (Device)
cross-over
Four periods separated by a wash out lasting up to 3 days at maximum. At each period, application of one product (twice). Duration of treatment period: From 4 to 13 days.
干预措施: Tested product : DC161-DP0293 (Device)
cross-over
Four periods separated by a wash out lasting up to 3 days at maximum. At each period, application of one product (twice). Duration of treatment period: From 4 to 13 days.
干预措施: Reference product: solution for oromucosal sprays (Device)
结局指标
主要结局
Observed area under the curve of dry mouth evaluations
时间窗: 11 points : from baseline (before application) and up to 4 hours after the first product application
Dry mouth will be self-rated using item "Rate the dryness of your mouth" of the Dry Mouth Visual Analogue Scale questions.
次要结局
未报告次要终点