UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000020168