Tokyo, May 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061000) titled 'Age-stratified analysis of gastrointestinal ulcer-related adverse events associated with tramadol and NSAIDs: a study using the JADER database' on May 1.
Study Type:
Observational
Primary Sponsor:
Institute - Aisei Pharmacy Co., Ltd.
Condition:
Condition - Pain-related conditions affecting the knee, spine, shoulder, hip, and lower extremities
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate age-stratified patterns of gastrointestinal adverse events, including peptic ulcer, gastrointestinal bleeding, and perforation, associated with tramadol use, and to clarify risk characteristics in elderly populations.
Basic objectives2 - Safety
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key 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
Key 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")
Target Size - 2000
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 04 Day
Date of IRB - 2025 Year 12 Month 09 Day
Anticipated trial start date - 2026 Year 01 Month 01 Day
Last follow-up date - 2026 Year 04 Month 04 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069807
Disclaimer: Curated by HT Syndication.
