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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021562
Receipt No. R000024863
Scientific Title Exploratory study for the efficacy and safety of Sansoninto on behavioral and psychological symptoms of dementia (BPSD) in patients with Dementia.: Multicenter trial
Date of disclosure of the study information 2016/03/22
Last modified on 2016/09/21

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Basic information
Public title Exploratory study for the efficacy and safety of Sansoninto on behavioral and psychological symptoms of dementia (BPSD) in patients with Dementia.: Multicenter trial
Acronym The efficacy and safety of Sansoninto on behavioral and psychological symptoms of dementia (BPSD) in patients with Dementia
Scientific Title Exploratory study for the efficacy and safety of Sansoninto on behavioral and psychological symptoms of dementia (BPSD) in patients with Dementia.: Multicenter trial
Scientific Title:Acronym The efficacy and safety of Sansoninto on behavioral and psychological symptoms of dementia (BPSD) in patients with Dementia
Region
Japan

Condition
Condition Dementia patients with BPSD
Classification by specialty
Neurology Geriatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate exploratively the efficacy and safety of Sansoninto on behavioral and psychological symptoms of Dementia in a single-armed, open-label study.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Changes in neuropsychiatric inventory (NPI) score before and 4 weeks after sansonintotreatment
Key secondary outcomes Changes in neuropsychiatric inventory (NPI) subscale before and 4 weeks after Sansoninto treatment

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 sansoninto for 4weeks
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Diagnosed to be dementia
2) Within normal limit of serum potassium.
3) HDS-R under 20
4) Agreement to sign an informed consent.
Key exclusion criteria 1) Patient who has an allergy to Sansoninto medicine.
2) Patients considered inappropriate by the study investigator.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiko Ogawa
Organization Kanazawa University
Division name Department of Kampo Medicine
Zip code
Address 13-1,Takara-machi, Kanazawa
TEL 076-265-2918
Email okeiko@med.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazumi Hirata
Organization Kanazawa University Hospital
Division name Department of Kampo Medicine
Zip code
Address 13-1, Takara-machi, Kanazawa
TEL 076-265-2918
Homepage URL
Email tomato.j2364832@gmail.com

Sponsor
Institute Kanazawa University
Institute
Department

Funding Source
Organization Kanazawa University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 金沢大学附属病院、映寿会みらい病院、田中町温泉病院

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 22 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 Enrolling by invitation
Date of protocol fixation
2016 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 25 Day
Last follow-up date
2016 Year 09 Month 30 Day
Date of closure to data entry
2016 Year 10 Month 31 Day
Date trial data considered complete
2016 Year 10 Month 31 Day
Date analysis concluded
2016 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 03 Month 22 Day
Last modified on
2016 Year 09 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024863

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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