UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005012 |
|---|---|
| Receipt number | R000005959 |
| Scientific Title | Evaulation of the clinical efficacy and safety of the combined administration of Imidafenacin and Tamsulosin in BPH patients (in which OAB symptoms remain) who did not respond to alpha-1 blocker monotherapy. |
| Date of disclosure of the study information | 2011/02/04 |
| Last modified on | 2013/08/05 11:58:55 |
* 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
Evaulation of the clinical efficacy and safety of the combined administration of Imidafenacin and Tamsulosin in BPH patients (in which OAB symptoms remain) who did not respond to alpha-1 blocker monotherapy.
Acronym
Addition Study
Scientific Title
Evaulation of the clinical efficacy and safety of the combined administration of Imidafenacin and Tamsulosin in BPH patients (in which OAB symptoms remain) who did not respond to alpha-1 blocker monotherapy.
Scientific Title:Acronym
Addition Study
Region
| Japan |
Condition
Condition
Overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Evaluate of the Effectiveness of Imidafenacin in Patients in Which OAB Symptoms Remain After the Administration of Tamsulosin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of total OABSS score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tamsulosin 0.2mg will be orally administered once a day after breakfast and Imidafenacin 0.1mg will be administered orally twice a day, once after breakfast and dinner for 52 weeks.
Interventions/Control_2
Tamsulosin 0.2mg will be orally administered once a day after breakfast for 12 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
(1)Benign prostatic hyperplasia
(2)Patients who have overactive bladder even after administering Tamsulosin for more than 8 weeks
(3)Outpatients who are 50 years older
(4)Residual urine volume is less than 50mL
(5)Prostate volume is more than 20mL
(6)Patients from whom we have received written consent
Key exclusion criteria
(1)Patients who have administered prohibited substances or who have administered prohibited therapy in the 8 weeks prior to the 1st period
(2)Patients who changed the dosage or usage of a restricted medicine in the specified period before the 1st period
(3)Patients with anuresis
(4)Patients with prostate cancer, neurogenic bladder, urethra stricture, chronic prostatitis, symptomatic urinary tract infection, urinary tract stones and interstitial cystitis
(5)Patients with serious cardiac disorder, serious liver dysfunction and serious kidney dysfunction
(6)Patients with orthostatic hypotension
(7)Patients with pyloristenosis,constriction of dodecadactylon, construction of enteron and adynamic ileus
(8)Patients with deterioration of enterokinesis
(9)Patients with angle-closure glaucoma
(10) Patients with myasthenia gravis.
(11) Patients in which it has been confirmed that Qmax is less than 5mL/s.
(12)Patients with Polyuria.
(13)Any other patients who are regarded as unsuitable for this study by the investigator
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Takeda |
Organization
University of Yamanashi
Division name
Department of Urology, School of Medicine
Zip code
Address
1110 Shimokato, Chuo, Yamanashi 409-3898 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
University of Yamanashi
Division name
Department of Urology, School of Medicine
Zip code
Address
1110 Shimokato, Chuo, Yamanashi 409-3898 Japan
TEL
Homepage URL
Sponsor or person
Institute
Department of Urology, University of Yamanashi, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
1) Nihon Univ.
2) Shinshu Univ.
3) Nagoya Univ.
4) Kumamoto Rosai Hospital
5) Sapporo Medical Univ.
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
| 2011 | Year | 02 | Month | 04 | 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
| 2010 | Year | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 11 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 03 | Day |
Last modified on
| 2013 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005959
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
