UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026273 |
|---|---|
| Receipt number | R000030172 |
| Scientific Title | A non-randomized, open-label, single arm study to evaluate the effect of Yokukansan on the dispositions of donepezil hydrochloride and risperidone (clinical pharmacokinetic analysis) |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2025/03/01 10:11:09 |
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Basic information
Public title
A non-randomized, open-label, single arm study to evaluate the effect of Yokukansan on the dispositions of donepezil hydrochloride and risperidone (clinical pharmacokinetic analysis)
Acronym
A study to evaluate the effect of Yokukansan on the dispositions of donepezil hydrochloride and risperidone
Scientific Title
A non-randomized, open-label, single arm study to evaluate the effect of Yokukansan on the dispositions of donepezil hydrochloride and risperidone (clinical pharmacokinetic analysis)
Scientific Title:Acronym
A study to evaluate the effect of Yokukansan on the dispositions of donepezil hydrochloride and risperidone
Region
| Japan |
Condition
Condition
Dementia or Schizophrenia
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate any effects of Yokukansan on the pharmacokinetics of donepezil hydrochloride and risperidone
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Variabilities in blood concentrations of donepezil hydrochloride, risperidone and their metabolites before and after co-treatment of Yokukansan
Key secondary outcomes
Variabilities in blood concentrations of donepezil hydrochloride, risperidone and their metabolites before and after co-treatment of Yokukansan according to the genotypes of pharmacokinetic related genes
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
8-week repeated doses of Yokukansan (7.5 g per day)
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with dementia who have been treated with donepezil hydrochloride for more than 4 weeks, or patients with schizophrenia who have been treated with risperidone for more than 2 weeks
Key exclusion criteria
Not available
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Junji |
| Middle name | |
| Last name | Saruwatari |
Organization
Graduate School of Pharmaceutical Sciences, Kumamoto University
Division name
Division of Pharmacology and Therapeutics
Zip code
862-0973
Address
5-1 Oe-honmachi, Chuo-ku, Kumamoto 862-0973, Japan
TEL
+81-96-371-4545
junsaru@gpo.kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Junji |
| Middle name | |
| Last name | Saruwatari |
Organization
Graduate School of Pharmaceutical Sciences, Kumamoto University
Division name
Division of Pharmacology and Therapeutics
Zip code
862-0973
Address
5-1 Oe-honmachi, Chuo-ku, Kumamoto 862-0973, Japan
TEL
+81-96-371-4545
Homepage URL
junsaru@gpo.kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Tsumura & Co
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
Faculty of Life Sciences, Kumamoto University
Address
1-1-1 Honjo, Chuo-ku, Kumamoto 860-8556, Japan
Tel
+81-96-373-5657
ski-shien@jimu.kumamoto-u.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
| 2017 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10
Number of participants that the trial has enrolled
23
Results
The plasma concentrations of donepezil and its metabolites (6-O-desmethyl-donepezil, 5-O-desmethyl-donepezil, and donepezil-N-oxide), risperidone, and its metabolite paliperidone did not differ before and after the 8-week treatment with yokukansan.
Results date posted
| 2025 | Year | 03 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 07 | Month | 08 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 23 | Day |
Last modified on
| 2025 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030172
