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

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 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

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

Value
https://center6.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