UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049753 |
|---|---|
| Receipt number | R000056549 |
| Scientific Title | A study to verify the efficacy of the selective SGLT2 inhibitor tofogliflozin hydrate in reducing nocturia |
| Date of disclosure of the study information | 2022/12/19 |
| Last modified on | 2024/07/06 09:42:05 |
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Basic information
Public title
A study to verify the efficacy of the selective SGLT2 inhibitor tofogliflozin hydrate in reducing nocturia
Acronym
The VESTITO Study
Scientific Title
A study to verify the efficacy of the selective SGLT2 inhibitor tofogliflozin hydrate in reducing nocturia
Scientific Title:Acronym
The VESTITO Study
Region
| Japan |
Condition
Condition
Nocturia coexisting with diabetes
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of changing SGLT2 inhibitor to tofogliflozin hydrate on nocturia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in nocturnal micturition frequency after 4 weeks
Key secondary outcomes
(1) Changes after 4 weeks: 24-hour urine volume, nocturnal urine volume, nocturnal polyuria index, N-QOL, PSQI
(2) Comparison at enrollment and 4 weeks later: HbA1c, serum Na
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The SGLT2 inhibitor will be changed to tofogliflozin hydrate.
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
- Sleep is interrupted more than once during the night to urinate.
- Nocturnal polyuria index more than 0.33 (more than 65 years old) or more than 0.20 (65 years old or younger)
- Taking a selective SGLT2 inhibitor other than tofogliflozin hydrate
Key exclusion criteria
HbA1c >8.5%
eGFR <45 mL/min/1.73m^2
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazumasa |
| Middle name | |
| Last name | Torimoto |
Organization
Kouseikai Takai Hospital
Division name
Urology
Zip code
632-0006
Address
470-8 Kuranosho-cho, Tenri, Nara
TEL
+81-743-65-0372
torimoto@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazumasa |
| Middle name | |
| Last name | Torimoto |
Organization
Kouseikai Takai Hospital
Division name
Urology
Zip code
632-0006
Address
470-8 Kuranosho-cho, Tenri, Nara
TEL
+81-743-65-0372
Homepage URL
torimoto@naramed-u.ac.jp
Sponsor or person
Institute
Department of Urology, Kouseikai Takai Hospital
Institute
Department
Personal name
Funding Source
Organization
Kouseikai Takai Hospital
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
Ethics Committee of Kouseikai Takai Hospital
Address
470-8 Kuranosho-cho, Tenri, Nara
Tel
+81-743-65-0372
kouseikai@takai-hp.com
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
高清会高井病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 19 | 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
| 2022 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 12 | Day |
Last modified on
| 2024 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056549
