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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000030330
Receipt No. R000034636
Scientific Title The preliminary prospective study of Treatment with A thiazide-based diuretic for Nocturnal polYuria associated with hypertensiOn
Date of disclosure of the study information 2017/12/12
Last modified on 2020/04/30

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Basic information
Public title The preliminary prospective study of Treatment with A thiazide-based diuretic for Nocturnal polYuria associated with hypertensiOn
Acronym TANYO study
Scientific Title The preliminary prospective study of Treatment with A thiazide-based diuretic for Nocturnal polYuria associated with hypertensiOn
Scientific Title:Acronym TANYO study
Region
Japan

Condition
Condition Nocturnal polyuria
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To prove the hypothesis that thiazide diuretic therapy for nocturnal polyuria improves sleep quality
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change in slow wave sleep time after 4 weeks from the start of administration
Key secondary outcomes Changes after 4 weeks from the start of administration
- Nocturnal polyuria index
- Nocturnal urinary volume
- Diurnal urinary volume
- Nocturnal excretoin of sodium in urine
- Diurnal excretoin of sodium in urine
- Total sleep time
- Sleep efficiency
- Body fluid

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral administration of trichlormethiazide 2 mg/day for 28 days
Interventions/Control_2 No treatment
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria - Nocturnal urinary frequency: twice and more
- Nocturnal polyuria index (nocturnal urine volume/24hr urine volume): 0.33 and more
- Comorbidity: hypertension
Key exclusion criteria - Administration of diuretics as antihypertensive drugs
- Untreated lower urinary tract dysfunction including benign prostatic hyperplasia
and overactive bladder
- Post-void residual urine: 100 mL and more
- Chronic renal disease: G3b and more (eGFR <45 mL/min/1.73m^2)
- Chronic heart failure: NYHA Class 3 or 4
- Insomnia associated with mental illness
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Kazumasa
Middle name
Last name Torimoto
Organization Nara Medical University
Division name Department of Urology
Zip code 634-8522
Address 840 Shijo-cho, Kashihara, Nara
TEL 0744-22-3051
Email torimoto@naramed-u.ac.jp

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Inoue
Organization Nara Medical University
Division name Department of Urology
Zip code 634-8522
Address 840 Shijo-cho, Kashihara, Nara
TEL 0744-22-3051
Homepage URL http://www.naramed-u.ac.jp/~urol/
Email you1513tt@yahoo.co.jp

Sponsor
Institute Department of Urology, Nara Medical University
Institute
Department

Funding Source
Organization Department of Urology, Nara Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nara Medical University Certified Review Board
Address 840 Shijo-cho, Kashihara, Nara
Tel 0744-29-8835
Email ethics_nara@naramed-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 奈良県立医科大学附属病院(奈良県)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 12 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 Terminated
Date of protocol fixation
2018 Year 01 Month 29 Day
Date of IRB
2018 Year 01 Month 29 Day
Anticipated trial start date
2018 Year 02 Month 01 Day
Last follow-up date
2020 Year 03 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 10 Day
Last modified on
2020 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034636

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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