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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008331
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Kobe University Graduate School of Medicine, Division of Urology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009804

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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