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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021729
Receipt No. R000024859
Scientific Title Efficacy of tadarafil for treating interstitial cystitis
Date of disclosure of the study information 2016/04/01
Last modified on 2016/07/13

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Basic information
Public title Efficacy of tadarafil for treating interstitial cystitis
Acronym Efficacy of tadarafil for treating interstitial cystitis
Scientific Title Efficacy of tadarafil for treating interstitial cystitis
Scientific Title:Acronym Efficacy of tadarafil for treating interstitial cystitis
Region
Japan

Condition
Condition Interstitial cystitis
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 For detecting an efficacy of tadarafil for treating interstitial cystitis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The symptoms improved rate after 12 weeks administration
Key secondary outcomes Change of cystoscopy findings,urinary frequency,voided volume after 12 weeks administration

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 2.5mg of tadarafil is administered 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients diagnosed as interstitial cystitis
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 the risk og tachycardia)
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 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryoichi Shiroki
Organization Fujita Health University
Division name Medicine/Department of Urology
Zip code
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
Middle name
Last name Hitomi Sasaki
Organization Fujita Health University
Division name Medicine/Department of Urology
Zip code
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
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
2016 Year 04 Month 01 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 Enrolling by invitation
Date of protocol fixation
2016 Year 03 Month 17 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 18 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
2016 Year 04 Month 01 Day
Last modified on
2016 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024859

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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