UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021959
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email kazi@kawahara.or.jp

Sponsor
Institute Kawahara Clinic
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025291

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.