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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030570
Receipt No. 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 2018/06/17

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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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Age: Patients with Down syndrome aged 15 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 -2SD (Siroky's nomogram) in uroflowmetry; and 3) urinary frequency of twice or less per day.
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
Middle name
Last name Hiroyuki Moriuchi
Organization Nagasaki University Hospital
Division name Department of Pediatrics
Zip code
Address 1-7-1 Sakamoto, Nagasaki City
TEL 095-819-7298
Email hiromori@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuro Kondoh
Organization The Misakaenosono Mutsumi Developmental, Medical and Welfare Center
Division name Division of Developmental Disabilities
Zip code
Address 570-1 Maki, Konagai-Cho, Isahaya City
TEL 0957-34-3113
Homepage URL
Email Kontatsu0721@gmail.com

Sponsor
Institute Department of Pediatrics, Nagasaki University Hospital
Institute
Department

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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2017 Year 12 Month 18 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 01 Day
Last follow-up date
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
2018 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034902

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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