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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000001912
Receipt No. R000002329
Scientific Title The development of a novel therapy using glycyrrhitinic acid for overactive bladder caused by lower urinary tract obstruction.
Date of disclosure of the study information 2009/11/01
Last modified on 2009/04/27

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Basic information
Public title The development of a novel therapy using glycyrrhitinic acid for overactive bladder caused by lower urinary tract obstruction.
Acronym Glycyrrhitinic acid for overactive bladder
Scientific Title The development of a novel therapy using glycyrrhitinic acid for overactive bladder caused by lower urinary tract obstruction.
Scientific Title:Acronym Glycyrrhitinic acid for overactive bladder
Region
Japan

Condition
Condition overactive bladder caused by lower urinary tract obstruction
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of glycyrrhetinic acid as a therapeutic drug for overactive bladder caused by lower urinary tract obstruction without impairment of urinary outlet.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The improvement of IPSS and OABSS compared with pre-thrapeutic data
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Therapeutic group
Interventions/Control_2
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
60 years-old <=
Age-upper limit
80 years-old >
Gender Male
Key inclusion criteria 60-80 years old BPH patients maintained of alpha blocking agent with overactive bladder symptom.
OABSS >5
Key exclusion criteria (1) Central nervous system disease
(2) Underactive bladder
(3) Active UTI
(4) active urothelial or prostatic cancer
(5) maintained on anticholinergics
(6) severe cardiac or renal dysfunction
(7) maintained on diuretics
(8) maintained on moxyfloxacin
(9) serum K <3.5
(10) judged inelligible by physician
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Osamu Ogawa
Organization Kyoto University
Division name Urology
Zip code
Address Shogoin Kawaracho54, Sakyo, Kyoto
TEL 075-751-3337
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akihrio Kanematsu
Organization Kyoto University
Division name Urology
Zip code
Address Shogoin Kawaracho54, Sakyo, Kyoto
TEL 075-751-3337
Homepage URL
Email aqui@kuhp.kyoto-u.ac.jp

Sponsor
Institute Urology, Kyoto University
Institute
Department

Funding Source
Organization Urology, Kyoto 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
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
2009 Year 11 Month 01 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 Preinitiation
Date of protocol fixation
2009 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2009 Year 05 Month 01 Day
Date of closure to data entry
2009 Year 11 Month 01 Day
Date trial data considered complete
2009 Year 11 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 04 Month 27 Day
Last modified on
2009 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002329

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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