UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018292 |
|---|---|
| Receipt number | R000020168 |
| Scientific Title | The efficacy and safety of Tadarafil for treatment of nocturia and sleep quality |
| Date of disclosure of the study information | 2015/07/13 |
| Last modified on | 2020/07/16 09:55:28 |
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Basic information
Public title
The efficacy and safety of Tadarafil for treatment of nocturia and sleep quality
Acronym
The efficacy of Tadarafil for nocturia and sleep disturbance
Scientific Title
The efficacy and safety of Tadarafil for treatment of nocturia and sleep quality
Scientific Title:Acronym
The efficacy of Tadarafil for nocturia and sleep disturbance
Region
| Japan |
Condition
Condition
Disease with lower urinary tract symptom
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For evaluating the efficacy of Tadarafil to nocturia and sleep disturbance
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Improving of urinary symptom score and sleep quality after 12 weeks medication
Key secondary outcomes
IPSS, QOL, OABSS, athene sleeing score, diary of urination
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
5mg of Tadarafil is administered to the patients once a day for 12 weeks
Interventions/Control_2
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1.Patients with nocturia(OABSS Total Score 3 or more and Q2 2 or more )
2.Patients who are considered eligible for the study by the attending physician
3.Patients who can understand the contents of the questionnaire without the help of others, and who can answer on their own
4.Patients who voluntarily provide written consent to participate in the study
Key exclusion criteria
1.Patients with a history of hypersensitivity to components of this drug
2.Patients with a history of serious cardiovascular (It have been reported heart rate increases, and there is a risk that symptoms worse.
3.Patients with severe hypertension
4.Patients with severe liver dysfunction (Child-Pugh score 10 or more) [There is a possibility that the blood concentration is excessively increased.]
5.Patients treated with flecainide acetate or propafenone hydrochloride in administration
6.Patients with chronic bacterial prostatitis or activity of urinary tract infection
7.Patients who carried the radiation therapy to the pelvis
8.Patients who suspected of having prostate cancer by PSA or rectal examination
9.Patients with urethral stricture
10.Patients who are considered ineligible for the study by the attending physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ryoichi |
| Middle name | |
| Last name | Shiroki |
Organization
Fujita Health University
Division name
Medicine/Department of Urology
Zip code
4701-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, JAPAN
TEL
0562-93-9257
rshiroki@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Sasaki |
Organization
Fujita Health University
Division name
Medicine/Department of Urology
Zip code
4701192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, JAPAN
TEL
0562-93-9257
Homepage URL
sasakih@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
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
Fujita Health University
Address
Toyoake
Tel
0562939257
sasakih@fujita-hu.ac.jp
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
| 2015 | Year | 07 | Month | 13 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 13 | Day |
Last modified on
| 2020 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020168
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