UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026822 |
|---|---|
| Receipt number | 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 | 2019/10/02 22:41:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 Severity and Drooling Frequency Scale.
Key secondary outcomes
this study evaluates the association between the dysphagia, extrapyramidal symptom and Drooling Severity and Drooling Frequency Scale.
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 | Ken |
| Middle name | |
| Last name | Iseki |
Organization
Hokkaido University Hospital
Division name
department of pharmacy
Zip code
060-8648
Address
Kita 14-jo Nishi 5-chome, Kita-ku,Sapporo-shi,Hokkaidou
TEL
011-716-1161
ken-i@pharm.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Shuhei |
| Middle name | |
| Last name | Ishikawa |
Organization
Hokkaido University Hospital
Division name
department of pharmacy
Zip code
060-8648
Address
Kita 14-jo Nishi 5-chome, Kita-ku,Sapporo-shi,Hokkaidou
TEL
011-716-1161
Homepage URL
s-ishikawa@huhp.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
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
Clinical Research and Medical Innovation Center
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-8648 Japan
Tel
011-706-7061
hcrmics@huhp.hokudai.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
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
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 05 | Month | 31 | Day |
Other
Other related information
observational study
Management information
Registered date
| 2017 | Year | 04 | Month | 01 | Day |
Last modified on
| 2019 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026313
