Single-blind, multicenter clinical study of donepezil hydrochloride for dysuria in patients with Down syndrome
Phase 3
Recruiting
- Conditions
- dysuria
- Registration Number
- JPRN-UMIN000030570
- Lead Sponsor
- Department of Pediatrics, Nagasaki University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
Not provided
Exclusion Criteria
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in maximum urinary flow rate (Qmax)
- Secondary Outcome Measures
Name Time Method Changes in average urinary flow rate (AFR), urinary patterns, residual urine volume, urinary frequency, frequency of urinary incontinence, defecation patterns, and activities of daily life