UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011755 |
|---|---|
| Receipt number | R000013742 |
| Scientific Title | Randomized comparative clinical study on alpha 1 receptor blockers silodosin and urapidil for female lower urinary tract symptoms |
| Date of disclosure of the study information | 2013/09/13 |
| Last modified on | 2018/03/18 09:38:09 |
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Basic information
Public title
Randomized comparative clinical study on alpha 1 receptor blockers silodosin and urapidil for female lower urinary tract symptoms
Acronym
Randomized comparative clinical study on silodosin and urapidil for female lower urinary tract symptoms
Scientific Title
Randomized comparative clinical study on alpha 1 receptor blockers silodosin and urapidil for female lower urinary tract symptoms
Scientific Title:Acronym
Randomized comparative clinical study on silodosin and urapidil for female lower urinary tract symptoms
Region
| Japan |
Condition
Condition
Lower urinary tract symptom
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the efficacy and safety of using silodosin for female lower urinary tract symptoms, using urapidil as a control drug.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
IPSS total score (at the initiation of administration, Week 4, Week 8, and Week 12)
Key secondary outcomes
I-PSS (QOL score), I-PSS (urinary storage symptom score), I-PSS (voiding symptom score), total OABSS score, residual urine measurement, urine flow measurement, blood pressure level, midway discontinuation rate, adverse drug reaction (at the initiation of administration, Week 4, Week 8, and Week 12) Pressure flow study, urination diary
(at the initiation of administration and Week 12)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
8 mg silodosin daily
Interventions/Control_2
60 mg urapidil 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Females aged 20 or older
Patient with total I-PSS score of 8 or higher and residual urine of 50 mL or more
Patient who can be examined at an outpatient clinic and from whom a written consent can be obtained on participation in the full scale study
Reasons for setting the conditions: I-PSS 8 or higher indicates moderate to severe levels of BPH, and this index can be used to assess urinary storage, voiding, and postmicturition symptoms comprehensively. Because the subjects of this study are patients whose major complaints are voiding symptoms, the condition of residual urine being 50mL and over was added as an objective finding.
Key exclusion criteria
Patient with serious comorbid heart disease (such as ischemic heart disease, serious arrythmia, myocardial disease, and myocarditis)
Patient with serious comorbid liver disease or total bilirubin level 3 mg/dL and over or AST(GOT) or ALT(GPT) 2.5 times and over the upper limit of the reference range
Patient with serious comorbid kidney disease (such as nephrotic syndrome, acute kidney disease, acute nephritis, and chronic renal failure) or serum creatinine level are 1.5mg/dL and over
Patient with serious hypotension
Woman who is pregnant, nursing, wishes to become pregnant during the study period, or cannot follow physician's instructions regarding contraception
Patient to whom urapidil was administered within 2 weeks of the initiation of the study
Patient to whom another kind of alpha receptor blocker has been administered
Patient for whom change or initiation of drug administration or change in dosage affecting urinary function was made within one month before initiation of the study
Patient who have undergone radiotherapy for the pelvis
Patient with active urinary tract infection
Patient whose symptoms are considered to aggravate rapidly (such as urinary retention) due to cessation of urapidil
Others judged to be unsuited as subjects according to the Principal Investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotsugu UEMURA |
Organization
Kinki University Faculty of Medicine
Division name
Department of Urology
Zip code
Address
377-2, Ohno-Higashi, Osaka-Sayama Osaka 589-8511, JAPAN
TEL
072-366-0221
huemura@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobutaka SHIMIZU |
Organization
Kinki University Faculty of Medicine
Division name
Department of Urology
Zip code
Address
377-2, Ohno-Higashi, Osaka-Sayama Osaka 589-8511, JAPAN
TEL
072-366-0221
Homepage URL
shimizun@med.kindai.ac.jp
Sponsor or person
Institute
Kinki University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kinki University Faculty of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2013 | Year | 09 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://www.ics.org/abstracts/abstractssearch.aspx
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
| 2013 | Year | 08 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 13 | Day |
Last modified on
| 2018 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013742
