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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000018292
Receipt No. 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

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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
Email 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
Email sasakih@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020168

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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