Local Application of Pilocarpine for Relieving Dry Mouth Complaints: A Randomized Controlled Pilot Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in xerostomia score (Numeric Rating Scale)
研究概览
简要总结
The investigators intended for this study to deliver the "proof-of-concept" that locally administered pilocarpine drops in two doses are effective in a population of elderly (aged ≥ 70 years) with xerostomia at the expense of limited adverse events. To this end, the study aims to quantify the effect size of pilocarpine in two different dosages. In case the investigators observe clinically meaningful changes in xerostomia through measured NRS, a sufficiently-powered RCT will be prepared to compare pilocarpine to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 70 years of age
- •Clinical diagnosis of chronic dry mouth defined as a Numeric Rating Scale (NRS) score ≥ 5 (scale 0 - 10, with 0 = no dry mouth and 10= worst possible dry mouth) on severity of xerostomia for more than 3 months.
排除标准
- •Existence of cognitive impairment and/or diagnosis of dementia appraised by treating physician
- •Inability to fill out the questionnaires due to other reasons
- •Prior radiation therapy of the head-and-neck region
- •Known m. Sjögren disease
- •Contra-indications for parasympathicomimetics (uncontrolled asthma, acute heart failure, active peptic ulceration, known hypersensitivity to pilocarpine, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle closure) glaucoma.
研究组 & 干预措施
Low dose pilocarpine
low dose pilocarpine = 3 x 2.0 mg = 3 x 2 drops of pilocarpine 20.0 mg/ml (2%) per day
干预措施: Pilocarpine Ophthalmic Solution (Drug)
High dose pilocarpine
high dose pilocarpine = 3 x 5.0 mg = 3 x 5 drops of pilocarpine 20.0 mg/ml (2%) per day
干预措施: Pilocarpine Ophthalmic Solution (Drug)
结局指标
主要结局
Change in xerostomia score (Numeric Rating Scale)
时间窗: 3 weeks
The Numeric Rating Scale is used to quantify the level of severity of xerostomia using a 0-10 cm Numeric Rating Scale ranging from 0 = no dry mouth to 10 = worst possible dry mouth
Change in oral health-related quality of life (Dutch Geriatric Oral Health Assessment Index)
时间窗: 2 weeks
Questionnaires assessing Oral health-related quality of life of adults, in particular older people is measured 4 times during this study by the doctor/research nurse . It comprises 12 items that measure three dimensions of Oral health-related quality of life: physical function items, psychosocial function and pain/discomfort.
次要结局
- Adverse effects(3 weeks)
- Global perceived effect(3 weeks)