UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021959 |
|---|---|
| Receipt number | R000025291 |
| Scientific Title | Study of the efficacy and safety of tadalafil and imidafenacin combination therapy for benign prostatic hyperplasia with overactive bladder |
| Date of disclosure of the study information | 2016/04/19 |
| Last modified on | 2017/03/15 12:03:44 |
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Basic information
Public title
Study of the efficacy and safety of tadalafil and imidafenacin combination therapy for benign prostatic hyperplasia with overactive bladder
Acronym
Study of the efficacy and safety of tadalafil and imidafenacin combination therapy for benign prostatic hyperplasia with overactive bladder
Scientific Title
Study of the efficacy and safety of tadalafil and imidafenacin combination therapy for benign prostatic hyperplasia with overactive bladder
Scientific Title:Acronym
Study of the efficacy and safety of tadalafil and imidafenacin combination therapy for benign prostatic hyperplasia with overactive bladder
Region
| Japan |
Condition
Condition
Benign prostatic hyperplasia patients with overactive bladder despite tadalafil treatment
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to enhance the treatment options for benign prostatic hyperplasia patients with persisting overactive bladder even after treatment with tadalafil by investigating the efficacy and safety of adding imidafenacin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The OABSS total score from baseline to 8 weeks
Key secondary outcomes
(1) OABSS subscore
(2) IPSS total, storage, voiding, QOL score
(3) BII
(4) Residual urine volume
(5) Maximum urinary flow rate
(6) Adverse events and side effects
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
Intervention group: imidafenacin(0.1 mg twice a day) will be additionally prescribed for 8 weeks to patients currently taking tadalafil(5mg/day)
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Patients must satisfy the following conditions at the first visit:
(1) 50 years old or above (at the time of obtaining consent)
(2) Overactive bladder despite taking tadalafil 5 mg per day for 4 weeks or more (OAB definition: 2 points or more for question 3 of the OABSS and 3 points or more for the OABSS total score)
(3) Prostate volume of at least 20 mL
(4) Outpatient
(5) Provided written consent for participation in this study
Key exclusion criteria
Patients who meet any of the following conditions at the first visit are excluded:
(1) Residual urine volume of 100 mL or more
(2) Suspicion of polyuria
(3) Currently have, or have a past history of, urinary retention
(4) Qmax of less than 5 mL/s
(5) Neoplasm of the lower urinary tract such as prostate or bladder cancer, neurogenic bladder, urethral stricture, chronic bacterial prostatitis, urinary tract infection, urinary tract stone, or interstitial cystitis
(6) Contraindication to the prescription of tadalafil or imidafenacin
(7) Severe liver dysfunction, kidney dysfunction, or heart disease
(8) Pyloric, duodenal, or other intestinal obstruction, decreased gastrointestinal motility or distention, paralytic ileus, closed angle glaucoma, or myasthenia gravis
(9) Taking a prohibited concurrent medication within 4 weeks prior to starting the study (5&alpha-reductase inhibitor, sex hormone agent within 6 months)
(10) Received a prohibited concurrent therapy within 8 weeks prior to starting the study
(11) Change in dose or regimen within 8 weeks prior to starting the study of a concurrent restricted medication or therapy
(12) Otherwise, determined to be inappropriate by the doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuya Kawahara |
Organization
Kawahara Clinic
Division name
Department of urolog
Zip code
Address
73-3,Nishimochida,Aira-city,Kagoshima 889-5431.Japan
TEL
099-564-5181
kazi@kawahara.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuya Kawahara |
Organization
Kawahara Clinic
Division name
Department of urology
Zip code
Address
73-3,Nishimochida,Aira-city,Kagoshima 889-5431.Japan
TEL
099-564-5181
Homepage URL
kazi@kawahara.or.jp
Sponsor or person
Institute
Kawahara Clinic
Institute
Department
Personal name
Funding Source
Organization
Kyorin Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 19 | 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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 19 | 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 | 18 | Day |
Last modified on
| 2017 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025291
