UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010553 |
|---|---|
| Receipt number | R000012339 |
| Scientific Title | A randomized controlled trial for beta agonist on ulolithiasis patients associated with overactive bladder. |
| Date of disclosure of the study information | 2013/05/01 |
| Last modified on | 2013/05/06 16:01:48 |
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Basic information
Public title
A randomized controlled trial for beta agonist on ulolithiasis patients associated with overactive bladder.
Acronym
A randomized controlled trial for beta agonist on ulolithiasis patients associated with overactive bladder.
Scientific Title
A randomized controlled trial for beta agonist on ulolithiasis patients associated with overactive bladder.
Scientific Title:Acronym
A randomized controlled trial for beta agonist on ulolithiasis patients associated with overactive bladder.
Region
| Japan |
Condition
Condition
urolithiasis
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to examine the efficacy of mirabegron for exclusion of urinary stones.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Stone free ratio after administration of drugs
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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
Mirabegron
Interventions/Control_2
Tolterodine tartrate
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) patients diagnosed as urolithiasis
2) patients associated with overactive bladder
3) Age; 20<=
4) ECOG performance status 0-1
5) Patiens have enough organ function
6) able to take mirabegron by mouth
7) agreement to sign an informed consent
8) on blood test
1.WBC>=3,000-<=12,000/mm3, 2.Neurtophils>=1,500/mm3
3. Platelets>=100,000/mm3
4. AST / ALT: not more than twice baseline
5. Total bilirubin<=3.0mg/dl
6. Hemoglobin>=9.0g/dl
8. Creatinine<= 2.0mg/dl
Key exclusion criteria
1) patients already receiving beta agonists
2) patients addicted to alcohol or drugs
3) contraindications cases of experimental drugs
4) pregnant or lactating women
5) individuals who are diagnosed as inappropriate for the trial.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Tanoguchi |
Organization
Isehara Kyodo Hospital
Division name
Department of Urology
Zip code
Address
2-17-1, Sakuradai ,Isehara city, Kanagawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Hongo |
Organization
Isehara Kyodo Hospital
Division name
Department of Urology
Zip code
Address
2-17-1, Sakuradai, Isehara city, Kanagawa
TEL
Homepage URL
Sponsor or person
Institute
Department of Urology, Isehara Kyodo Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
伊勢原協同病院（神奈川県）、稲城市立病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | 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
| 2013 | Year | 03 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 21 | Day |
Last modified on
| 2013 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012339
| Research Plan | |
|---|---|
| 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 |
