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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007973
Receipt No. 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

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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
Email 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
Email narihito@kyushu-ctr-hsp.com

Sponsor
Institute FUN(Fukuoka Urology Network)
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009387

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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