UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048684 |
|---|---|
| Receipt number | R000055471 |
| Scientific Title | Validation research study on migraine (Validation research study using questionnaire surveys and health insurance association medical claim data) |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2023/06/06 16:58:30 |
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Basic information
Public title
Validation research study on migraine
(Validation research study using questionnaire surveys and health insurance association medical claim data)
Acronym
Validation research study on migraine
Scientific Title
Validation research study on migraine
(Validation research study using questionnaire surveys and health insurance association medical claim data)
Scientific Title:Acronym
Validation research study on migraine
Region
| Japan |
Condition
Condition
Migraine
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to evaluate the validity (reliability) of the definition of migraine diagnoses based on health insurance association medical claim data using the classification of migraine based on the questionnaire survey as true.
Basic objectives2
Others
Basic objectives -Others
The objective is to evaluate the validity (reliability) of the definition of migraine diagnoses based on health insurance association medical claim data using the classification of migraine based on the questionnaire survey as true.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PPV (PPV:Positive Predictive Value)
Key secondary outcomes
Sensitivity
Specificity
NPV (NPV: Negative Predictive Value)
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
| 19 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
These included those from whom responses were received a when a self-administered web questionnaire survey on headache and QOL was conducted (from November 1, 2020 to November 30, 2020) among health insurance association members (approximately 600,000 individuals) who agreed to the secondary use of medical data and who have contracts with DeSC, and were aged 19 to less than 75 years who were registered in kencom, an app for health promotion support services provided by DeSC (approximately 150,000 individuals).
Key exclusion criteria
none
Target sample size
21480
Research contact person
Name of lead principal investigator
| 1st name | kentaro |
| Middle name | |
| Last name | yamato |
Organization
Otsuka Pharmaceuticals Co., Ltd
Division name
Medical Affairs Department
Zip code
108-8242
Address
Grand Central Tower 2-16-4 konan,Minato-ku,Tokyo
TEL
03-6717-1400
Yamato.Kentaro@otsuka.jp
Public contact
Name of contact person
| 1st name | kentaro |
| Middle name | |
| Last name | yamato |
Organization
Otsuka Pharmaceuticals Co., Ltd
Division name
Medical Affairs Department
Zip code
108-0242
Address
Grand Central Tower 2-16-4 konan,Minato-ku,Tokyo
TEL
03-6717-1400
Homepage URL
Yamato.Kentaro@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceuticals Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The research ethics committee of Otsuka Pharmaceutical Co., Ltd
Address
463-10 Kagasuno,Kawauchi-cho,Tokushima-city,Tokushima
Tel
088-665-2126
Imaizumi.Takashi@otsuka.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
| 2022 | Year | 09 | 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
21480
Results
Using a questionnaire linked claim data,we examined the most appropriate receipt conditions for migraine subjects identified by the ICHD-3 and 2 screeners.The most common combination of the PPV was "at least two migraine diagnoses and at least one prescription of migraine prophylaxis or triptans in the same month as the migraine diagnosis", suggesting that these were appropriate conditions for the migraine patients identified in the ICHD-3 condition
Results date posted
| 2023 | Year | 02 | Month | 19 | Day |
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
| 2022 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 08 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 08 | Month | 17 | Day |
Last modified on
| 2023 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055471
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
