Clinical Trial: 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 (Japan)

Tokyo, Aug. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062444) titled '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)' on Aug. 3.

Study Type: Observational

Primary Sponsor: Institute - The University of Osaka, Graduate School of Medicine Faculty of Medicine

Condition: Condition - Influenza Classification by malignancy - Others Genomic information - NO

Objective: 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

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 Size - 1962306

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071464

Disclaimer: Curated by HT Syndication.