UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030560 |
|---|---|
| Receipt number | 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 | 2020/01/02 13:04:35 |
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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 | Masashi |
| Middle name | |
| Last name | Honda |
Organization
Department of Surgery, Tottori University Faculty of Medicine
Division name
Dvision of Urology
Zip code
6838504
Address
36-1 Nishicho, Yonago, Tottori, Japan
TEL
0859-38-6607
honda@tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Honda |
Organization
Department of Surgery, Tottori University Faculty of Medicine
Division name
Dvision of Urology
Zip code
6838504
Address
36-1 Nishicho, Yonago, Tottori, Japan
TEL
0859-38-6607
Homepage URL
honda@tottori-u.ac.jp
Sponsor or person
Institute
Division of Urology, Department of Surgery, Tottori University Faculty of Medicine
Institute
Department
Personal name
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
Tottori University Faculty of Medicine Ethics Committee
Address
36-1 Nishicho, Yonago, Tottori, Japan
Tel
0859-33-1111
me-rinshoukenkyu@ml.adm.tottori-u.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
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
| 2016 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 25 | Day |
Last modified on
| 2020 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034891
