UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025820 |
|---|---|
| Receipt number | R000029691 |
| Scientific Title | Personalized medication for overactive bladder with imidafenacin treatment |
| Date of disclosure of the study information | 2017/03/15 |
| Last modified on | 2019/02/05 12:30:57 |
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Basic information
Public title
Personalized medication for overactive bladder with imidafenacin treatment
Acronym
PERMIT study
Scientific Title
Personalized medication for overactive bladder with imidafenacin treatment
Scientific Title:Acronym
PERMIT study
Region
| Japan |
Condition
Condition
Overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The comparison of impact on the quality of life between personalized and controlled dosage of medicine for overactive bladder
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
King's Health Questionnaire
Key secondary outcomes
Overactive bladder symptom score (OABSS)
IPSS-QOL score
adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
[Personalized medication]
First 2 weeks: imidafenacin 0.1mg x 2/day (Fixed)
Following 3-12 weeks: imidafenacin 0.1-0.4mg/day depending on the subjective decision of the patients
Interventions/Control_2
[Controlled medication]
First 2 weeks: imidafenacin 0.1mg x 2/day (Fixed)
Following 3-12 weeks: imidafenacin 0.2-0.4mg/day depending on the objective decision of the doctors
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
Female
Key inclusion criteria
OABSS: urgency score 3 and more, and total score 6 and more
Key exclusion criteria
- Urinary retention within the last 12 months
- Post-void residual urine 100mL and more
- Indwelling catheter or Intermittent catheterization
- Sleep apnea syndrome, Restless legs syndrome or insomnia
- acute urinary infection
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazumasa Torimoto |
Organization
Nara Medical University
Division name
Urology
Zip code
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
torimoto@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazumasa Torimoto |
Organization
Nara Medical University
Division name
Urology
Zip code
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
torimoto@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
Organization
Division
Category of Funding Organization
Self funding
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
| 2017 | Year | 03 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 20 | 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
| 2017 | Year | 01 | Month | 24 | Day |
Last modified on
| 2019 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029691
| Research Plan | |
|---|---|
| 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 |
