UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004153
Receipt number R000004985
Scientific Title A Crossover trial of Furosemide versus Gosha-Jinki-Gan for Nocturnal Polyuria
Date of disclosure of the study information 2010/09/10
Last modified on 2012/03/05 16:43:45

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Basic information

Public title

A Crossover trial of Furosemide versus Gosha-Jinki-Gan for Nocturnal Polyuria

Acronym

A Crossover trial of Furosemide versus Gosha-Jinki-Gan for Nocturnal Polyuria

Scientific Title

A Crossover trial of Furosemide versus Gosha-Jinki-Gan for Nocturnal Polyuria

Scientific Title:Acronym

A Crossover trial of Furosemide versus Gosha-Jinki-Gan for Nocturnal Polyuria

Region

Japan


Condition

Condition

Nocturia due to nocturnal polyuria

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the efficacy and the safety of furosemide and gosha-jinki-gan for nocturia due to nocturnal polyuria

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

nocturnal urinary frequency and nocturnal polyuria index

Key secondary outcomes

safety, quality of life, serum BNP level, blood pressure, body fluid compartments


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

furosemide, peroral administration, 20mg after lunch, once per day

Interventions/Control_2

gosha-jinki-gan, peroral administration, 7.5g/day, 3 times/day

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

50 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) 2 or more of I-PSS nocturia score
2) 35% or more of nocturnal polyuria index
3) 50 or more of age
4) systolic blood pressure 140mmHg or more, or diastolic blood pressure 90mmHg or more, or under treatment of hypertension
5) 20pg/ml or more and less than 200 pg/ml of serum BNP level

Key exclusion criteria

1) obvious neurogenic bladder
2) severe hypertension
3) severe complications

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koji Yoshimura

Organization

Kyoto University Graduate School of Medicine

Division name

Urology

Zip code


Address

54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Koji Yoshimura

Organization

Kyoto University Graduate School of Medicine

Division name

Urology

Zip code


Address


TEL


Homepage URL


Email

ky7527@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Department of Urology, Kyoto University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

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


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

2010 Year 09 Month 10 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.wiley.com/bw/journal.asp?ref=1757-5664&site=1

Number of participants that the trial has enrolled


Results

Both furosemide and GJG significantly improved the nocturia score in the I-PSS, the I-PSS QOL score, actual nocturnal frequency and hours of undisturbed sleep compared with those at baseline. Nocturnal frequency and nocturnal urine volume were more significantly reduced by furosemide treatment than with GJG treatment. The I-PSS total score and nocturnal urine volume significantly improved only by furosemide treatment.

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

2006 Year 09 Month 15 Day

Date of IRB


Anticipated trial start date

2006 Year 12 Month 01 Day

Last follow-up date

2010 Year 12 Month 01 Day

Date of closure to data entry

2010 Year 12 Month 01 Day

Date trial data considered complete

2010 Year 12 Month 01 Day

Date analysis concluded

2010 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2010 Year 09 Month 02 Day

Last modified on

2012 Year 03 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004985


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name