UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017261 |
|---|---|
| Receipt number | R000020012 |
| Scientific Title | Effect of Tamsulosin for Benign Prostate Hyperplasia patient with persistent symptoms: switch from Silodosin. |
| Date of disclosure of the study information | 2015/04/24 |
| Last modified on | 2015/11/25 10:42:44 |
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Basic information
Public title
Effect of Tamsulosin for Benign Prostate Hyperplasia patient with persistent symptoms: switch from Silodosin.
Acronym
Effect of Tamsulosin for Benign Prostate Hyperplasia patient with persistent symptoms: switch from Silodosin.
Scientific Title
Effect of Tamsulosin for Benign Prostate Hyperplasia patient with persistent symptoms: switch from Silodosin.
Scientific Title:Acronym
Effect of Tamsulosin for Benign Prostate Hyperplasia patient with persistent symptoms: switch from Silodosin.
Region
| Japan |
Condition
Condition
Benign prostatic hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine efficacy and safety of switch from Silodosin to 0.2 mg Tamsulosin.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
International Prostate Symptom score
Key secondary outcomes
Base
Study type
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
To examine efficacy and safety of switch from Silodosin to 0.2 mg Tamsulosin. (12weeks)
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1. male patients aged 50 or older
2. patients treated with Silodosin 8mg for over 8 weeks
3. question number 3 of QOL score: 3 points or more
4. patients with lower urinary tract symptoms (IPSS: 8 points or more, QOL score 3 points or more)
5. patients who want to change from Silodosin to Tamsulosin
6. patients with informed consent
Key exclusion criteria
1. patients treated with other alpha 1 blocker
2. patients Tamsulosin is contraindicated
3. patients treated with anti cholonergic agents
4. patients treated with anti androgen agents
5. patients treated with drug could change urination
6. patients with prostate cancer
7. patients with the history of TUR-P
8. patients with the history of hyperthermia for benign prostatic hyperplasia
9. patients with neurogenic bladder
10. patients with urethral stricture
11. patients with using self catheterization
12. patients with the history of radiation therapy
13. patients with active urinary infection
14. patients who have been determined to be unsuitable as a subject by a physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiko Mitsui |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Renal and Genitourinary surgery
Zip code
Address
North 15, West 7, Kita-ku, Sapporo, 060-8638, Japan
TEL
011-706-5966
mitsui68@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiko Mitsui |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Renal and Genitourinary surgery
Zip code
Address
North 15, West 7, Kita-ku, Sapporo, 060-8638, Japan
TEL
011-706-5966
Homepage URL
mitsui68@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
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
| 2015 | Year | 04 | Month | 24 | 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
Completed
Date of protocol fixation
| 2010 | Year | 04 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 03 | 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
| 2015 | Year | 04 | Month | 23 | Day |
Last modified on
| 2015 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020012
| 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 |
