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
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
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
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
