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 | 2024/03/22 10:00:25 |
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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
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
No longer recruiting
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
| 2024 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030172
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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