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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026822
Receipt No. R000026313
Scientific Title Identification of a risk factor for clozapine-induced sialorrhea
Date of disclosure of the study information 2017/04/01
Last modified on 2017/04/01

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Basic information
Public title Identification of a risk factor for clozapine-induced sialorrhea
Acronym Identification of a risk factor for CIS
Scientific Title Identification of a risk factor for clozapine-induced sialorrhea
Scientific Title:Acronym Identification of a risk factor for CIS
Region
Japan

Condition
Condition schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is to clarify the relationship between the blood concentration of clozapine and metabolite and the occurrence of clzoapine-induced sialorrhea.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes this study evaluates the association between the blood concentration of clozapine and metabolite and Drooling Frequency Scale, Drooling Severity Scale and Saxon test.
Key secondary outcomes this study evaluates the association between the blood concentration of clozapine and metabolite and gene polymorphism for transporter.

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patient taking clozapine
Key exclusion criteria Patient changing dosage of clozapine
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Iseki
Organization Hokkaido University Hospital
Division name department of pharmacy
Zip code
Address Kita 14-jo Nishi 5-chome, Kita-ku,Sapporo-shi,Hokkaidou
TEL 011-716-1161
Email ken-i@pharm.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shuhei Ishikawa
Organization Hokkaido University Hospital
Division name department of pharmacy
Zip code
Address Kita 14-jo Nishi 5-chome, Kita-ku,Sapporo-shi,Hokkaidou
TEL 011-716-1161
Homepage URL
Email s-ishikawa@huhp.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
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 北海道大学病院(北海道)

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 Preinitiation
Date of protocol fixation
2016 Year 12 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information observational study

Management information
Registered date
2017 Year 04 Month 01 Day
Last modified on
2017 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026313

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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