UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030570 |
|---|---|
| Receipt number | R000034902 |
| Scientific Title | Single-blind, multicenter clinical study of donepezil hydrochloride for dysuria in patients with Down syndrome |
| Date of disclosure of the study information | 2018/01/04 |
| Last modified on | 2024/07/02 12:46:00 |
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Basic information
Public title
Single-blind, multicenter clinical study of donepezil hydrochloride for dysuria in patients with Down syndrome
Acronym
A study of donepezil hydrochloride for dysuria in Down syndrome
Scientific Title
Single-blind, multicenter clinical study of donepezil hydrochloride for dysuria in patients with Down syndrome
Scientific Title:Acronym
A study of donepezil hydrochloride for dysuria in Down syndrome
Region
| Japan |
Condition
Condition
dysuria
Classification by specialty
| Pediatrics | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effectiveness of donepezil hydrochloride for dysuria in patients with Down syndrome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Change in maximum urinary flow rate (Qmax)
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Donepezil hydrochloride
Interventions/Control_2
placebo
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
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.
Key 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.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Moriuchi |
Organization
Nagasaki University Hospital
Division name
Department of Pediatrics
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki City
TEL
095-819-7298
hiromori@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuro |
| Middle name | |
| Last name | Kondoh |
Organization
The Misakaenosono Mutsumi Developmental, Medical and Welfare Center
Division name
Division of Developmental Disabilities
Zip code
859-0164
Address
570-1 Maki, Konagai-Cho, Isahaya City
TEL
0957-34-3113
Homepage URL
Kontatsu0721@gmail.com
Sponsor or person
Institute
Department of Pediatrics, Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
(1) Department of Urology, Nagasaki University Hospital
(2) Department of Urology, Saga University Hospital
(3) The Misakaenosono Mutsumi Developmental, Medical and Welfare Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Clinical Research Review Board in Nagasaki University
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
Tel
095-819-7905
gaibushikin@ml.nagasaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 26 | Day |
Last modified on
| 2024 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034902
