UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011556 |
|---|---|
| Receipt number | R000013520 |
| Scientific Title | Comparative Study of Early Efficacy of Once-Daily Dosing between Silodosin 4mg and Tamsulosin 0.2mg for Voiding Symptoms Associated with Benign Prostatic Hyperplasia |
| Date of disclosure of the study information | 2013/08/26 |
| Last modified on | 2015/05/14 19:00:08 |
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Basic information
Public title
Comparative Study of Early Efficacy of Once-Daily Dosing between Silodosin 4mg and Tamsulosin 0.2mg for Voiding Symptoms Associated with Benign Prostatic Hyperplasia
Acronym
Comparative Study of Early Efficacy of Once-Daily Dosing between Silodosin 4mg and Tamsulosin 0.2mg for Voiding Symptoms Associated with Benign Prostatic Hyperplasia
Scientific Title
Comparative Study of Early Efficacy of Once-Daily Dosing between Silodosin 4mg and Tamsulosin 0.2mg for Voiding Symptoms Associated with Benign Prostatic Hyperplasia
Scientific Title:Acronym
Comparative Study of Early Efficacy of Once-Daily Dosing between Silodosin 4mg and Tamsulosin 0.2mg for Voiding Symptoms Associated with Benign Prostatic Hyperplasia
Region
| Japan |
Condition
Condition
Benign Prostatic Hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is intended for elderly patients aged 65 years or older with moderate or severe voiding symptoms associated with benign prostatic hyperplasia. The subjects will be randomized to receive silodosin 4 mg or tamsulosin 0.2 mg once daily after breakfast for 4 weeks. Efficacy in early stages after administration and safety will be compared between the 2 groups.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IPSS voiding symptom score
Key secondary outcomes
(1) Efficacy;
IPSS total score and subscores
QOL score
OABSS
Urodynamic parameters
(2) Safety;
Blood pressure
Adverse events and adverse drug reactions
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Silodosin 4 mg, once daily after breakfast
Interventions/Control_2
Tamsulosin 0.2 mg, once daily after breakfast
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
(1)Subject must have urinary symptoms associated with benign prostatic hyperplasia.
(2)Subject must give written informed consent.
(3)Subject must satisfy the following conditions during screening conducted at the start of the treatment period (Day 0):
* the total IPSS voiding symptom score is 8 or more,
* the QOL score is 2 or more,
* prostate volume is 20 mL or more,
* maximum urinary flow rate (Qmax) is 15 mL/sec or less, and
* residual urine volume is less than 100 mL.
(4)Subject must not use prohibited concomitant drugs except at least 2 weeks before the start of the treatment period (Day 0), or the subject must be able to undergo a drug washout for at least 2 weeks before the start of the treatment period.
(5)Subject must be an outpatient who can fill in the questionnaire.
(6)Subject must be 65 years or older at the time of signing the informed consent.
Key exclusion criteria
(1)Subject is contraindicated to silodosin or tamsulosin according to the respective package insert.
(2)Subject has received prostatic resection.
(3)Subject has received radiotherapy to the pelvic region.
(4)Subject has received hyperthermia or thermotherapy for prostatic hypertrophy.
(5)Subject has or is suspected to have prostate cancer.
(6)Subject has neurogenic overactive bladder, bladder neck contracture, urethral stricture, bladder stones, large bladder diverticulum, active urinary tract infection requiring treatment, or other complications that may affect urination.
(7)Subject performs self-catheterization.
(8)Subject has taken any of the following drugs within 12 months before the start of treatment period (Day 0):
* silodosin or tamsulosin,
* 5alpha-reductase inhibitors, or
* antiandrogen drugs.
(9)Subject has clinically important cardiovascular disturbances.
(10)Subject has clinically important hepatorenal diseases.
(11)Subject has a history of severe drug hypersensitivity.
(12)Subject is scheduled to have cataract surgery in the study period.
(13)Subject has or is suspected to have a complication of dementia.
(14)Subject is considered inappropriate for participating in the study by the subinvestigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masami Matsushita |
Organization
Matsushita Urology Clinic
Division name
Director
Zip code
Address
459 Minamitada Usui-no-tsubo, Kaibara-cho, Tanba-shi, Hyogo
TEL
0795-73-0266
kzkk77731@leto.eonet.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Orie Watanabe |
Organization
Sogo Rinsho Médéfi Co., Ltd
Division name
Business Promotion Department
Zip code
Address
3-2-7 Nishi-shinjuku, Shinjuku-ku, Tokyo
TEL
03-6901-6079
Homepage URL
watanabe.orie@sogo-medefi.jp
Sponsor or person
Institute
Matsushita Urology Clinic
Institute
Department
Personal name
Funding Source
Organization
KISSEI PHARMACEUTICAL CO.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2013 | Year | 08 | Month | 26 | 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
| 2013 | Year | 07 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2015 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 22 | Day |
Last modified on
| 2015 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013520
