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Influence of acetaminophen on liver function: A cohort study using a real world database

Influence of acetaminophen on liver function: A cohort study using a real world database - Influence of acetaminophen on liver function: A cohort study using a real world database

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000045199
Enrollment
Unknown
Registered
2021-08-20
Start date
2021-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug-induced liver injury

Interventions

None listed

Sponsors

AYUMI PHARMACEUTICAL CO., LTD
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who have been prescribed either oral acetaminophen or NSAIDs (loxoprofen/celecoxib) for 28 consecutive days or longer

Exclusion criteria

Exclusion criteria: Patients with virus hepatitis (B15-B19), alcoholic hepatitis (K70), or a hepatic disorder name defined as a clinical outcome

Design outcomes

Primary

MeasureTime frame
Incidence rates of hepatic disease and ALT > male 126U/L,female 69U/L(JCOG>3*ULN). Non-inferiority of acetaminophen to NSAIDs with respect to risk of hepatotoxicity will be considered to be demonstrated if the 95% confidence interval of rate ratio below the non-inferiority margin of 1.39. This margin was set using a fixed-margin method based on a meta-analysis of randomized placebo-controlled trials.—

Countries

Japan

Contacts

Public ContactMasahiro Okamoto

AYUMI PHARMACEUTICAL CO., LTD Medical Affairs Div.

masahiro.okamoto@ayumi-pharma.com0362643530

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026