UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007973 |
|---|---|
| Receipt number | R000009387 |
| Scientific Title | Evaluation of the clinical efficacy and safety of the combined administration of Imidafenacin and alfa1-blocker in BPH patients with OAB. |
| Date of disclosure of the study information | 2012/05/17 |
| Last modified on | 2016/12/14 16:09:31 |
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Basic information
Public title
Evaluation of the clinical efficacy and safety of the combined administration of Imidafenacin and alfa1-blocker in BPH patients with OAB.
Acronym
FUN Study
Scientific Title
Evaluation of the clinical efficacy and safety of the combined administration of Imidafenacin and alfa1-blocker in BPH patients with OAB.
Scientific Title:Acronym
FUN 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 clinical efficacy and safety of the combined administration of Inidafenacin and alfa1-blocker in BPH patients with OAB.
Basic objectives2
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
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1) Benign prostatic hyperplasia
2) Patients who have overactive bladder even after administering alfa1-blocker (Silodosin or Naftopidil) for more than 4 weeks
3) Age more than 50 years
4) Prostate volume is more than 20mL or less than 50ml
5) Patients from whom we have received consent
Key exclusion criteria
1) Patients who have administered prohibited substances or done prohibited therapy within the 4 weeks before enrollment. (Sex hormone drug and 5-alpha reductase inhibitor within the 52 weeks before enrollment.)
2) Patients who changed the dosage or usage of a restricted medicine within the 4 weeks before enrollment
3) Patients with prostate cancer, neurogenic bladder, urethra stricture, chronic prostatitis, symptomatic urinary tract infection, urinary tract stones and interstitial cystitis
4) Patients with anuresis
5) Patients with pyloristenosis, constriction of dodecadactylon, construction of enteron and adynamic ileus
6) Patients with deterioration of enterokinesis
7) Patients with angle-closure glaucoma
8) Patients with myasthenia gravis
9) Patients with serious cardiac disorder, serious liver dysfunction and serious kidney dysfunction
10) Patients with history of hypersensitive reaction to anticholinergic agents
11) Residual urine volume is more than 50mL
12) Patients in which it has been confirmed that Qmax is less than 5mL/s
13) Patients with Polyuria
14) Any other patients who are regarded as unsuitable for this study by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Narihito Seki |
Organization
Kyushu Central Hospital
Division name
Urology
Zip code
Address
23-1, Shiobaru 3-chome, Minami-ku, Fukuoka-shi, Fukuoka, Japan
TEL
092-541-4936
narihito@kyushu-ctr-hsp.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Narihito Seki |
Organization
Kyushu Central Hospital
Division name
Urology
Zip code
Address
23-1, Shiobaru 3-chome, Minami-ku, Fukuoka-shi, Fukuoka, Japa
TEL
092-541-4936
Homepage URL
narihito@kyushu-ctr-hsp.com
Sponsor or person
Institute
FUN(Fukuoka Urology Network)
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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
公立学校共済組合 九州中央病院（福岡県）、医療法人社団邦生会 高山病院（福岡県）、日本海員掖済会門司病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 17 | 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
| 2012 | Year | 05 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) OABSS score
2) IPSS/QOL score
3) BII score
4) Residual urine volume
5) Qmax
6) Adverse drug reaction
Management information
Registered date
| 2012 | Year | 05 | Month | 17 | Day |
Last modified on
| 2016 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009387
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
