UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002119 |
|---|---|
| Receipt number | R000002581 |
| Scientific Title | exploratory randomized clinical traial comparing naftopidil with tamsulosin in cases with benign prostatic hypertrophy assciated with overactive bladder |
| Date of disclosure of the study information | 2009/06/24 |
| Last modified on | 2014/12/19 18:23:16 |
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Basic information
Public title
exploratory randomized clinical traial comparing naftopidil with tamsulosin in cases with benign prostatic hypertrophy assciated with overactive bladder
Acronym
exploratory randomized clinical traial comparing naftopidil with tamsulosin in cases with benign prostatic hypertrophy assciated with overactive bladder
Scientific Title
exploratory randomized clinical traial comparing naftopidil with tamsulosin in cases with benign prostatic hypertrophy assciated with overactive bladder
Scientific Title:Acronym
exploratory randomized clinical traial comparing naftopidil with tamsulosin in cases with benign prostatic hypertrophy assciated with overactive bladder
Region
| Japan |
Condition
Condition
Benign prostatic hypertophy associated with overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To campare naftopidil with tamsulosin as to the efficacy for overactive bladder in cases with benign prostatic hypertrophy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
grade of desire for voiding measured by frequency volume chart
Key secondary outcomes
frequency of voiding, maximum voiding volume, average voiding volume
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
naftopidil 25mg to 75mg daily
Interventions/Control_2
tamsulosin 0.2mg daily
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1. previously untreated cases with benign prostatic hypertrophy
2. prostatic volume>=20ml
3. IPSS total score>=8 and QOL score>=2
4. Question 2 of IPSS>=2
5. Question 4 of IPSS>=2
Key exclusion criteria
1. residual volume>=50ml
2. cases with prostatic cancer, bladder cancer or interstitial cystitis
3. cases with urethral stricture
4. cases with diseases which may affect on the lower urinary tract symptoms such as diabate mellitus, cerebral vascular disease and spinal cord injury
5. cases with past history of allergic reaction to naftopidil or tamsulosin
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukio Homma |
Organization
the University of Tokyo Hospital
Division name
Department of Urology
Zip code
Address
7-3-1 Hongo Bunkyo-ku, Tokyo 113-8655, Japan
TEL
+81-3-5800-8662
kumeh-uro@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruki Kume |
Organization
the University of Tokyo Hospital
Division name
Department of Urology
Zip code
Address
7-3-1 Hongo Bunkyo-ku, Tokyo 113-8655, Japan
TEL
+81-3-5800-8662
Homepage URL
kumeh-uro@h.u-tokyo.ac.jp
Sponsor or person
Institute
Department of Urology, the University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
Nihon University, Bokutoh Hospital, Tokyo Kyosai Hospital, Police Hospital, Fraternity Memorial Hospital, Geriatric Hospital, Japan Red Cross Medical Center, Misato Kenwa Hospital
Name of secondary funder(s)
None
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
東京大学医学部附属病院、The University of Tokyo Hospital
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 06 | 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
| 2008 | Year | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 15 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 24 | Day |
Last modified on
| 2014 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002581
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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