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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004140
Receipt No. 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

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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 &#8805;200ml
prostate malignancy; or, a prostatic specific antigen of &#8805;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
Email

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
Email

Sponsor
Institute Department of Urology Tohoku University School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004972

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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