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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030560
Receipt No. R000034891
Scientific Title Comparison of tadalafil monotherapy and its combination with mirabegron for efficacy in the treatment of storage symptoms with benign prostatic hyperplasia
Date of disclosure of the study information 2017/12/25
Last modified on 2017/12/25

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Basic information
Public title Comparison of tadalafil monotherapy and its combination with mirabegron for efficacy in the treatment of storage symptoms with benign prostatic hyperplasia
Acronym Comparison of tadalafil monotherapy and its combination with mirabegron for efficacy in the treatment of storage symptoms with benign prostatic hyperplasia
Scientific Title Comparison of tadalafil monotherapy and its combination with mirabegron for efficacy in the treatment of storage symptoms with benign prostatic hyperplasia
Scientific Title:Acronym Comparison of tadalafil monotherapy and its combination with mirabegron for efficacy in the treatment of storage symptoms with benign prostatic hyperplasia
Region
Japan

Condition
Condition Benign prostatic hyperplasia
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of tadalafil monotherapy and its combination with mirabegron for storage symptoms with benign prostatic hyperplasia
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overactive bladder symptom score (OABSS)
Key secondary outcomes Number of night urination
International prostate symptom score
Overactive bladder-questionnaire (OAB-q)
Nocturia-quality of life (N-QOL)

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A monotherapy group, which continuously received 5 mg tadalafil daily for 8 weeks.
Interventions/Control_2 An add-on group, which received 5mg tadalafil daily and 50 mg mirabegron daily for 4 weeks after 5 mg tadalafil daily for 4 weeks.
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
50 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria The study included men with benign prostatic hyperplasia. Inclusion criteria are total OABSS 3 or greater with urinary urgency at least once per week, IPSS question 7 score 2 or greater and age 50 years or greater.
Key exclusion criteria Study exclusion criteria are post-void residual urine volume greater than 100 ml, acute urinary retention, neurogenic bladder dysfunction, severe bladder diverticulum or urethral stricture, urinary tract malignant disease, previous intrapelvic irradiation, renal or hepatic impairment, severe cardiac disease, or considered unsuitable for the trial by doctors.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masashi Honda
Organization Department of Surgery, Tottori University Faculty of Medicine
Division name Dvision of Urology
Zip code
Address 36-1 Nishicho, Yonago, Tottori, Japan
TEL 0859-38-6607
Email honda@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masashi Honda
Organization Department of Surgery, Tottori University Faculty of Medicine
Division name Dvision of Urology
Zip code
Address 36-1 Nishicho, Yonago, Tottori, Japan
TEL 0859-38-6607
Homepage URL
Email honda@med.tottori-u.ac.jp

Sponsor
Institute Tottori University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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 鳥取大学医学部附属病院(鳥取県)、鳥取赤十字病院(鳥取県)、鳥取県立中央病院(鳥取県)、山陰労災病院(鳥取県)、米子医療センター(鳥取県)、済生会境港病院(鳥取県)、松江市立病院(島根県)、松江赤十字病院(島根県)、松江生協病院(島根県)、浜田医療センター(島根県)、津山第一病院(岡山県)、吉野三宅ステーションクリニック(鳥取県)、わたなべクリニック(鳥取県)、みはらクリニック(鳥取県)、山本泌尿器クリニック(鳥取県)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 25 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 Open public recruiting
Date of protocol fixation
2016 Year 08 Month 04 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 22 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
2017 Year 12 Month 25 Day
Last modified on
2017 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034891

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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