UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012640 |
|---|---|
| Receipt number | R000014771 |
| Scientific Title | Observational study to assess dose-up efficacy of anticholinergic agent on nocturia in overactive bladder patients |
| Date of disclosure of the study information | 2013/12/20 |
| Last modified on | 2016/12/14 16:27:27 |
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Basic information
Public title
Observational study to assess dose-up efficacy of anticholinergic agent on nocturia in overactive bladder patients
Acronym
Observational study to assess dose-up efficacy of anticholinergic agent on nocturia in overactive bladder patients(Dose Flex Study)
Scientific Title
Observational study to assess dose-up efficacy of anticholinergic agent on nocturia in overactive bladder patients
Scientific Title:Acronym
Observational study to assess dose-up efficacy of anticholinergic agent on nocturia in overactive bladder patients(Dose Flex Study)
Region
| Japan |
Condition
Condition
Overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe the change of nocturia symptom in OAB patients (IPSS Q7(nocturia score >=3))
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in IPSS Q7 (nocturia score) as change in nocturnal voids
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who are regarded as overactive bladder at the start of dosing imidafenacin
2)Patients who have the follow criteria even after administering imidafenacin for more than 4 weeks
IPSS Q7(nocturia score) >=3
3)Aged >=20 years
Key exclusion criteria
1)Patients with contraindications for imidafenacin
2)Patients who have current condition of severe difficulty of urination
3)Patients who have history of urinary retention
4)Patients with serious kidney dysfunction
5)Residual urine volume > 50 mL
6)Patients with cancer in bladder, cystoliths, urinary tract infection, recurrent urinary tract infection or interstitial cystitis
7)Patients with polyuria
8)Patients who have administered prohibited substances or done prohibited therapy in the 4 weeks prior to the start of study (excepting operations on urinary and sexual organs)
9)Patients who have been operated on the urinary or sexual organs in the 6 months prior to the start of study
10)Patients with unstable lower urinary tract symptoms
11)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 | Yasuyuki Suzuki |
Organization
Tokyo Metropolitan Rehabilitation Hospital
Division name
Department of Medical Care
Zip code
Address
2-14-1 Tutumidori Sumida-Ward, Tokyo
TEL
03-3616-8600
ysuro@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Suzuki |
Organization
Tokyo Metropolitan Rehabilitation Hospital
Division name
Department of Medical Care
Zip code
Address
2-14-1 Tutumidori Sumida-Ward, Tokyo
TEL
03-3616-8600
Homepage URL
ysuro@jikei.ac.jp
Sponsor or person
Institute
Clinical Research Support Center Kyushu
Institute
Department
Personal name
Funding Source
Organization
Kyorin Pharmaseutical 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
| 2013 | Year | 12 | Month | 20 | 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
| 2013 | Year | 12 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2015 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 08 | Month | 31 | Day |
Other
Other related information
Prospective observational study
Management information
Registered date
| 2013 | Year | 12 | Month | 20 | 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=R000014771
