UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001912 |
|---|---|
| Receipt number | 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 22:35:10 |
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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
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
aqui@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Urology, Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002329
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
