UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008331 |
|---|---|
| Receipt number | R000009804 |
| Scientific Title | A COMPARATIVE STUDY ON THE CLINICAL EFFECTS OF SILODOSIN AND NAFTOPIDIL IN JAPANESE PATIENTS WITH LOWER URINARY TRACT SYMPTOMS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA |
| Date of disclosure of the study information | 2012/07/03 |
| Last modified on | 2012/07/03 17:30:09 |
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Basic information
Public title
A COMPARATIVE STUDY ON THE CLINICAL EFFECTS OF SILODOSIN AND NAFTOPIDIL IN JAPANESE PATIENTS WITH LOWER URINARY TRACT SYMPTOMS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA
Acronym
A COMPARATIVE STUDY ON THE CLINICAL EFFECTS OF SILODOSIN AND NAFTOPIDIL IN JAPANESE PATIENTS WITH LOWER URINARY TRACT SYMPTOMS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA
Scientific Title
A COMPARATIVE STUDY ON THE CLINICAL EFFECTS OF SILODOSIN AND NAFTOPIDIL IN JAPANESE PATIENTS WITH LOWER URINARY TRACT SYMPTOMS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA
Scientific Title:Acronym
A COMPARATIVE STUDY ON THE CLINICAL EFFECTS OF SILODOSIN AND NAFTOPIDIL IN JAPANESE PATIENTS WITH LOWER URINARY TRACT 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
A COMPARATIVE STUDY ON THE CLINICAL EFFECTS OF SILODOSIN AND NAFTOPIDIL IN JAPANESE PATIENTS WITH LOWER URINARY TRACT SYMPTOMS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IPSS Score, QOL Score, Blood pressure
Key secondary outcomes
maximum urinary flow rate (Qmax), residual urine volume
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
The patients have never received alpha-blocker before the enrollment. After the enrollment, patients were randomized to receive silodosin 4mg twice daily or naftopidil 50mg once daily for 8weeks.
Interventions/Control_2
The patients are receiving tamuslosin 0.2mg once daily at the enrollment. After the enrollment, patients were randomized to receive silodosin 4mg twice daily or naftopidil 50mg once daily for 8weeks.
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
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
1) Men aged over 50 and under 80 years old
2) International Prostate Symptom Score (IPSS) of>7
3) a prostate volume of >20ml
4) a maximum urinary flow rate (Qmax) of <15ml/s
Key exclusion criteria
1) Patients are having the disease other than a benign prostatic hyperplasia (prostate cancer, bladder tumors, bladder stones, prostatitis, bladder neck sclerosis, patients, etc.)
2) Patients have received TUR-P, balloon dilation, urethral stent, hyperthermia, or radiation therapy to the pelvis, within 6 months of the start of the study
3) Self-catheterization
4)Patients with urinary tract infection
5) Patients with concomitant disease and other nervous system diseases, and it suspected to be neurogenic bladder
6) Patients with concomitant severe ischemic heart disease, cerebrovascular disease, liver dysfunction, renal dysfunction.
7) Patients with hypotension
8) Patients are having hypersensitivity to silodosin, naftopidil or taking vardenafil hydrochloride
9) Patients have treated with hormonal drug within 6 months
10) Patients treated with drugs other than tamsulosin is considered effective on urinary symptoms within a week
11) Patients was deemed by the physician as inappropriate to attend
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Fujisawa |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Urology
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiro Shirakawa |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Urology
Zip code
Address
TEL
078-382-6155
Homepage URL
Sponsor or person
Institute
Kobe University Graduate School of Medicine, Division of Urology
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kobe Century Memorial Hospital,
Shakaihoken Kobe Central Hospital,
Kobe Ekisaikai Hospital,
Hyogo Prefectural Amagasaki Hospital
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
| 2012 | Year | 07 | Month | 03 | 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
| 2007 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 03 | Day |
Last modified on
| 2012 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009804
