UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062444 |
|---|---|
| Receipt number | R000071464 |
| Scientific Title | Initial NSAID versus acetaminophen prescribing at influenza diagnosis and 14-day neuropsychiatric claims among adults aged 18-64 years: a target trial emulation in a Japanese claims database |
| Date of disclosure of the study information | 2026/08/03 |
| Last modified on | 2026/08/03 10:51:56 |
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Basic information
Public title
A study of whether starting an NSAID versus acetaminophen at the time of influenza diagnosis is associated with neuropsychiatric diagnoses (such as encephalopathy, seizures, altered consciousness, and psychiatric symptoms) within 14 days, using a health insurance claims database (mainly adults aged 18-64 years)
Acronym
NSAID-Influenza Neuropsychiatric Study (JMDC)
Scientific Title
Initial NSAID versus acetaminophen prescribing at influenza diagnosis and 14-day neuropsychiatric claims among adults aged 18-64 years: a target trial emulation in a Japanese claims database
Scientific Title:Acronym
NSAID-Influenza TTE Study (JMDC)
Region
| Japan |
Condition
Condition
Influenza
Classification by specialty
| Neurology | Infectious disease | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using the JMDC Claims Database, to compare initial systemic (oral or rectal) NSAID versus single-agent acetaminophen prescribed at influenza diagnosis, and to evaluate whether the 14-day risk of a newly recorded neuropsychiatric composite outcome (from the day after time zero, the influenza diagnosis date) differs between treatments, within an active-comparator, new-user target trial emulation framework. The principal analytic population is adults aged 18-64 years, and the average treatment effect in the overlap population is estimated by overlap weighting.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
A broad neuropsychiatric composite newly recorded on days 1-14 after time zero, comprising acute neurological events (seizures/convulsions, encephalitis/encephalopathy, altered consciousness, meningitis, acute movement disorders) and psychiatric events (psychosis, mood disorders, organic mental disorders including delirium, self-harm). Each component is counted as incident only if the same component was not diagnosed in the 365 days up to and including time zero. Overlap-weighted 14-day absolute risks, risk differences, and risk ratios (95% CI) are estimated.
Key secondary outcomes
Key secondary outcomes: (1) a neurological-only definition, an acute-CNS subset (seizure, encephalitis/encephalopathy, altered consciousness, meningitis), a mood-excluded composite, and an inpatient composite. (2) A specific influenza-associated encephalopathy endpoint (inpatient flagged diagnosis plus a supporting procedure). (3) Component-specific counts. Sensitivity analyses: adding same-day severity markers, excluding the time-zero antiviral indicator, a day-3 landmark analysis (excluding events on days 1-2), analyses restricted by continued enrollment, and ingredient-specific analyses. The full cohort and age strata (children, 18-64, 65-74, 75 years and older) are examined as secondary and exploratory analyses.
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
Episodes with a non-suspect influenza diagnosis (ICD-10 J09-J11) and a same-day, same-facility single-agent oral or rectal NSAID or acetaminophen prescription. New use (no target antipyretic in the prior 180 days), new episode (no influenza diagnosis in the prior 30 days), at least 365 days of baseline and at least 14 days of follow-up observable, and no specific-encephalopathy diagnosis on day 0 or in the prior 365 days. One eligible first episode per person was analysed (index period 28 September 2018 to 17 March 2025). The principal analytic population was adults aged 18-64 years (children, 65-74, and 75 years and older were exploratory strata).
Key exclusion criteria
Episodes with both eligible treatment classes (NSAID and acetaminophen) linked to an influenza diagnosis on the index date were excluded at the patient-date level. Also excluded: prior use of a target antipyretic within 180 days (not new use), an influenza diagnosis within the prior 30 days, inability to observe 365 days of baseline or 14 days of follow-up, and a specific-encephalopathy diagnosis on day 0 or in the prior 365 days. Five episodes identified as non-NSAID during final code-list review were excluded.
Target sample size
1962306
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kutsuna |
Organization
The University of Osaka, Graduate School of Medicine Faculty of Medicine
Division name
Department of Infection Prevention and Control
Zip code
565-0871
Address
2-2, Yamadaoka, Suita city
TEL
0836-6879-5111
kutsuna@hp-infect.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kutsuna |
Organization
The University of Osaka, Graduate School of Medicine Faculty of Medicine
Division name
Department of Infection Prevention and Control
Zip code
565-0871
Address
2-2, Yamadaoka, Suita city
TEL
0836-6879-5111
Homepage URL
kutsuna@hp-infect.med.osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka, Graduate School of Medicine Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
The University of Osaka
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
The University of Osaka Hospital, Ethical Review Board
Address
2-15, Yamadaoka, Suita city
Tel
0836-6879-5111
rinri@hp-crc.med.osaka-u.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
大阪大学大学院医学系研究科 感染制御学 / The University of Osaka, Graduate School of Medicine
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 03 | 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
1962306
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
| 2026 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 03 | Day |
Date of closure to data entry
| 2026 | Year | 08 | Month | 03 | Day |
Date trial data considered complete
| 2026 | Year | 08 | Month | 03 | Day |
Date analysis concluded
| 2026 | Year | 08 | Month | 03 | Day |
Other
Other related information
This is a retrospective target trial emulation (active-comparator, new-user design) using the JMDC Claims Database (insurer and later-stage elderly databases; data observation period September 2018 to March 2025). Initial systemic NSAID versus acetaminophen prescribed at influenza diagnosis were compared, and the average treatment effect on a 14-day neuropsychiatric composite outcome was estimated in the propensity-score overlap-weighted population. The principal analytic population was adults aged 18-64 years. Existing anonymized data were analysed after institutional review board approval.
Management information
Registered date
| 2026 | Year | 08 | Month | 03 | Day |
Last modified on
| 2026 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071464
