Age-stratified analysis of gastrointestinal ulcer-related adverse events associated with tramadol and NSAIDs: a study using the JADER database

Age-stratified disproportionality analysis of gastrointestinal ulcer-related adverse events associated with tramadol and NSAIDs using the Japanese Adverse Drug Event Report (JADER) database - TRAMADOL-GI risk Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000061000

Enrollment

2000

Registered

2026-05-01

Start date

2026-01-01

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

Pain-related conditions affecting the knee, spine, shoulder, hip, and lower extremities

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Cases in the JADER database in which tramadol, tramadol/acetaminophen combination, NSAIDs (e.g., diclofenac, loxoprofen, celecoxib, naproxen), or acetaminophen are reported as suspected drugs 2) Cases with available age information (20-60 years and >=70 years) recorded in the demo table

Exclusion criteria

Exclusion criteria: 1) Cases in which the drug name cannot be clearly identified 2) Cases with missing or unknown age classification (e.g., "unknown", "not reported")

Design outcomes

Primary

Measure	Time frame
Reporting odds ratio (ROR) and 95% confidence interval for gastrointestinal adverse events (including ulcer, bleeding, perforation, necrosis, enteritis, gastritis, and melena) associated with tramadol use in the JADER database (analysis period: entire available dataset)	—

Secondary

Measure	Time frame
1) Reporting odds ratio (ROR) and proportional reporting ratio (PRR) for gastrointestinal adverse events associated with NSAIDs and acetaminophen 2) Comparison of adverse event counts, ROR, and PRR between age groups (20-60 years vs >=70 years) 3) Changes in ROR and PRR based on stratified analyses by concomitant NSAIDs use, antiplatelet/anticoagulant therapy, and renal impairment 4) Exploratory signal detection using empirical Bayes geometric mean (EBGM) and information component (IC) (analysis period: entire available dataset)	—

Measure

Time frame

1) Reporting odds ratio (ROR) and proportional reporting ratio (PRR) for gastrointestinal adverse events associated with NSAIDs and acetaminophen 2) Comparison of adverse event counts, ROR, and PRR between age groups (20-60 years vs >=70 years) 3) Changes in ROR and PRR based on stratified analyses by concomitant NSAIDs use, antiplatelet/anticoagulant therapy, and renal impairment 4) Exploratory signal detection using empirical Bayes geometric mean (EBGM) and information component (IC) (analysis period: entire available dataset)

—

Countries

Japan

Contacts

Public ContactShingo Nemoto

Aisei Pharmacy Co., Ltd. Kanagawa Branch

sentaminami@aisei.co.jp03-3240-0222

Outcome results