UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030330 |
|---|---|
| Receipt number | 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 18:13:36 |
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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
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/
you1513tt@yahoo.co.jp
Sponsor or person
Institute
Department of Urology, Nara Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034636
