UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045002 |
|---|---|
| Receipt number | R000051399 |
| Scientific Title | Survey of migraine in headache disorders- based on receipt data of health insurance insured persons and questionnaire survey - |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2023/06/06 17:00:35 |
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Basic information
Public title
Survey of migraine in headache disorders -based on receipt data of health insurance insured persons and questionnaire survey -
Acronym
Survey of migraine in headache disorders- based on receipt data of health insurance insured persons and questionnaire survey -
Scientific Title
Survey of migraine in headache disorders- based on receipt data of health insurance insured persons and questionnaire survey -
Scientific Title:Acronym
Survey of migraine in headache disorders- based on receipt data of health insurance insured persons and questionnaire survey -
Region
| Japan |
Condition
Condition
Migraine
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to grasp present state of migraine medical care in the headache disease and effect and challenge of headache/migraine on the daily life, the actual condition is investigated using questionnaire survey result and receptor data for health insurance union studies.
Basic objectives2
Others
Basic objectives -Others
investigate the actual condition
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Daily life impairment and health-related QOL of migraine
Trouble with a headache(reasons for stopping taking migraine medication and reasons for forgetting to take it)
Burden of people with headaches (daily life / visiting a health care institution)
Prevalence of migraine and other headache disorders
Percentage of visiting a health care institution for migraine and other headache diseases
Status of taking migraine remedies
Key secondary outcomes
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals with response data from a questionnaire-based survey conducted by DeSC.
Key exclusion criteria
None
Target sample size
20000
Research contact person
Name of lead principal investigator
| 1st name | Riyo |
| Middle name | |
| Last name | Inuyama |
Organization
Otsuka Pharmaceuticals Co., Ltd
Division name
Medical Affairs Department
Zip code
108-8242
Address
Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo
TEL
03-6717-1400
Inuyama.Lyo@otsuka.jp
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | Sano |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Medical Affairs Department
Zip code
540-0021
Address
3-2-27 Ote-dori,Chuo-ku,Osaka
TEL
06-6943-7722
Homepage URL
sanoh@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceuticals Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceuticals Co., Ltd
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
RIHDS research ethics committee
Address
inside JMDC Co., Ltd Sumitomo Shibadaimon Building,2-5-5 Shibadaimon, Minato-ku, Tokyo,
Tel
03-5733-5010
rihds@jmdc.co.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
| 2021 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000051399
Publication of results
Published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000051399
Number of participants that the trial has enrolled
21704
Results
Analysis of 21,480 population showed that the prevalence of migraine was 3.2%, 4.4 times higher in women than in men, and higher in patients aged 30-39 years. Among migraine patients, 81.0% have not visited a hospital, more than 80% were taking over-the-counter medications, and 6.1% were taking prescription medications only. About 52.9% of the patients reported that the intensity of their pain symptoms was "severe" and 72.9% reported moderate or greater impairment in activities of daily living.
Results date posted
| 2023 | Year | 02 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Health insurance association members aged 19 to 74 who are registered with the health promotion support service application "kencom".
Participant flow
A survey of health insurance association members was conducted via the Kencom application.
Adverse events
This was a retrospective study utilizing a secondary data source using ICD diagnosis codes as described in the protocol, and individual case safety information were not generated or collected. Information obtained from this study didn't subject to individual case safety reporting because anonymized data prevented follow-up of data required for ICSR. We didn't find new safety information from this study.
Outcome measures
Prevalence of Migraine
MS-QOL
WPAI
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 08 | Month | 24 | Day |
Other
Other related information
In order to grasp present state of migraine medical care in the headache disease and effect and challenge of headache/migraine on the daily life, the actual condition is investigated using questionnaire survey result and receptor data for health insurance union studies.
Management information
Registered date
| 2021 | Year | 07 | Month | 29 | Day |
Last modified on
| 2023 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051399
