UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060191 |
|---|---|
| Receipt number | R000068810 |
| Scientific Title | A Real-World Analysis of Temporal Trends in the Use of Insomnia Medications Using an Insurer Claims Database |
| Date of disclosure of the study information | 2025/12/26 |
| Last modified on | 2025/12/23 15:23:05 |
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Basic information
Public title
A Real-World Analysis of Temporal Trends in the Use of Insomnia Medications Using an Insurer Claims Database
Acronym
A Real-World Analysis of Temporal Trends in the Use of Insomnia Medications Using an Insurer Claims Database
Scientific Title
A Real-World Analysis of Temporal Trends in the Use of Insomnia Medications Using an Insurer Claims Database
Scientific Title:Acronym
A Real-World Analysis of Temporal Trends in the Use of Insomnia Medications Using an Insurer Claims Database
Region
| Japan |
Condition
Condition
Insomnia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using a Japanese health insurance claims database, we analyzed prescribing patterns of insomnia medications among adults with insomnia in 2016 and 2021, focusing on patients with specific comorbidities.
Basic objectives2
Others
Basic objectives -Others
Descriptive statistics of patient background.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Characterization of patients prescribed insomnia medications (age, comorbidities, etc.) and assessment of prescribing patterns by medication class
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Insomnia Medication-Prescribed Patient Cohort
Individuals aged 18 years or older in fiscal year 2016 or 2021 who had an insomnia-related ICD-10 diagnosis (G47.0 or F51.0) and received at least one prescription for insomnia medications classified as ORA (N05CJ), BZD (N05CD), Z-drug (N05CF), or MRA (N05CH).
Comorbidity Cohort
Among individuals aged 18 years or older in fiscal year 2016 or 2021 who had an insomnia-related ICD-10 diagnosis (G47.0 or F51.0) and received at least one prescription for insomnia medications classified as ORA (N05CJ), BZD (N05CD), Z-drug (N05CF), or MRA (N05CH), those with specific comorbidities (ICD-10) that showed an increased frequency or were prespecified by clinical experts as having high clinical relevance.
Key exclusion criteria
No exclusion criteria were specified.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yoshi |
| Middle name | |
| Last name | Yasuda |
Organization
Daiichi Sankyo Co., Ltd.
Division name
Primary Medical Science Department
Zip code
103-8426
Address
3-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan
TEL
03-6225-1111
yoshi.yasuda@daiichisankyo.com
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Suedomi |
Organization
Daiichi Sankyo Co., Ltd.
Division name
Primary Medical Science Department
Zip code
103-8426
Address
3-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan
TEL
03-6225-1111
Homepage URL
tomohiro.suedomi@daiichisankyo.com
Sponsor or person
Institute
Daiichi Sankyo Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Self-funded
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
Daiichi Sankyo Co., Ltd.
Address
3-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan
Tel
03-6225-1111
tomohiro.suedomi@daiichisankyo.com
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
| 2025 | Year | 12 | Month | 26 | 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
| 2025 | Year | 10 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Repeated cross-sectional study
Management information
Registered date
| 2025 | Year | 12 | Month | 24 | Day |
Last modified on
| 2025 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068810
