UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037525 |
|---|---|
| Receipt number | R000042777 |
| Scientific Title | The impact of dry mouth on adherence of anticholinegic agent |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2023/01/30 12:12:44 |
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Basic information
Public title
The impact of dry mouth on adherence of anticholinegic agent
Acronym
Dry mouth by anticholinegic agent
Scientific Title
The impact of dry mouth on adherence of anticholinegic agent
Scientific Title:Acronym
Dry mouth by anticholinegic agent
Region
| Japan |
Condition
Condition
Overactive bladder, Neurogenic bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To research the dry mouth and adherence of anticholinegic agent
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adherence of anticholinegic agent
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
The patients having overactive bladder or neurogenic bladder with dry mouth by anticholinegic agents
Key exclusion criteria
The patients having allergy by capsaicin or royal jelly
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Masumori |
Organization
Sapporo Medical University
Division name
Department of Urology
Zip code
060-8543
Address
S. 1, W. 16, Chuo-ku, Sapporo
TEL
0116112111
masumori@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kyoda |
Organization
Sapporo Medical University
Division name
Department of Urology
Zip code
060-8543
Address
S. 1, W. 16, Chuo-ku, Sapporo
TEL
0116112111
Homepage URL
kyohday@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University
Address
S. 1, W. 16, Chuo-ku, Sapporo
Tel
0116112111
ji-rskk@sapmed.ac.jp
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
| 2019 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
20
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Statistical Analysis of the study has not been finished.
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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients record the adherence of anticholinegic agent during two weeks after entry to this study.
Management information
Registered date
| 2019 | Year | 07 | Month | 29 | Day |
Last modified on
| 2023 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042777
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
