JPRN-jRCTs071180032招募中2 期
Single-blind, multicenter clinical study of donepezil hydrochloride for dysuria in patients with Down syndrome
Moriuchi Hiroyuki0 个研究点目标入组 48 人开始时间: 2019年3月6日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 12age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Age: Patients with Down syndrome aged 12 years old or above at the time when consent is obtained.
- •Gender: Both male and female.
- •Inpatients/Outpatients: Only outpatients.
- •Dysuria is defined as any of the following: 1) a postvoid residual urine 20% or more of voided urine volume or 50 mL or more; 2) Qmax less than -1SD (Siroky's nomogram) in uroflowmetry; and 3) urinary frequency of twice or less per day. 4)Average urinary volume more than 600ml.
- •Patients and their family or guardian must voluntarily give a written consent to participation in this study with full understanding after sufficient explanation.
- •Only patients who have been under other medical treatment for dysuria with an insufficient effect are eligible for this study.
排除标准
- •Any of the following patients will be excluded:
- •1) those who have already taken any acetylcholinesterase inhibitor with high CNS selectivity, including Aricept
- •2) those with serious liver or kidney dysfunction
- •3) those with drug hypersensitivity
- •4) those who have been in remission on other medical therapy such as Urapidil
- •5) those who have been on treatment with other therapeutic agent(s) for dysuria
- •6) those who need to change therapeutic strategy within 8 weeks of the single-blind study
- •7) those whom principal investigator judged as inappropriate for this study.
研究者
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