UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004140 |
|---|---|
| Receipt number | R000004972 |
| Scientific Title | Morning vs evening dosing with tamusuosin in benign prostatic hyperplasia with nocturia patients:Multi-center Randomized Control trial |
| Date of disclosure of the study information | 2010/08/31 |
| Last modified on | 2010/12/18 12:43:12 |
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Basic information
Public title
Morning vs evening dosing with tamusuosin in benign prostatic hyperplasia with nocturia patients:Multi-center Randomized Control trial
Acronym
RCT on PRO-Dosing
Scientific Title
Morning vs evening dosing with tamusuosin in benign prostatic hyperplasia with nocturia patients:Multi-center Randomized Control trial
Scientific Title:Acronym
RCT on PRO-Dosing
Region
| Japan |
Condition
Condition
Prostate hypertrophy
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clear the effect of alpha-blockers between Morning vs evening dosing in benign prostatic hyperplasia with nocturia patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
number of night time voiding episode
Key secondary outcomes
IPSS
IPSS QoL
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
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
dosing in the morning
Interventions/Control_2
dosing in the evening
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
the patients of prostate hypertrophy with nocturia
Key exclusion criteria
prostate surgery
any co-existing condition that that may affect micturition, such as neurogenic bladder, bladder neck contracture, urethral stricture, urinary tract infection, bladder cancer, or acute or chronic prostatitis
bladder stones
acute urinary retension
residural urine volume of ≥200ml
prostate malignancy; or, a prostatic specific antigen of ≥10ng/ml unless biopsy had ruled out prostatic cancer
apparent dimentia patient.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruo Nakagawa |
Organization
Tohoku University
Division name
Department of Urology
Zip code
Address
1-1 Seiryo-machi Aoba-ku Sendai
TEL
022-717-7278
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tohoku University
Division name
Department of Urology
Zip code
Address
TEL
022-717-7278
Homepage URL
Sponsor or person
Institute
Department of Urology Tohoku University School of Medicine
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
Tohoku Rosai Hospital
Ogachi Central Hospital
NTT East Sendai Hospital
Iwaki Urological Hospital
Kesennuma City Hospital
Osaki City Hospital
Kaneto Urology-Renal Clinic
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
| 2010 | Year | 08 | Month | 31 | 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
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 31 | Day |
Last modified on
| 2010 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004972
