UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061000 |
|---|---|
| Receipt number | R000069807 |
| Scientific Title | Age-stratified disproportionality analysis of gastrointestinal ulcer-related adverse events associated with tramadol and NSAIDs using the Japanese Adverse Drug Event Report (JADER) database |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/04/19 09:56:12 |
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Basic information
Public title
Age-stratified analysis of gastrointestinal ulcer-related adverse events associated with tramadol and NSAIDs: a study using the JADER database
Acronym
TRAMADOL-GI Risk Study (Signal Analysis)
Scientific Title
Age-stratified disproportionality analysis of gastrointestinal ulcer-related adverse events associated with tramadol and NSAIDs using the Japanese Adverse Drug Event Report (JADER) database
Scientific Title:Acronym
TRAMADOL-GI risk Study
Region
| Japan |
Condition
Condition
Pain-related conditions affecting the knee, spine, shoulder, hip, and lower extremities
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
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)
Key secondary outcomes
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)
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
| 20 | years-old | <= |
Age-upper limit
| 120 | 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 sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Nemoto |
Organization
Aisei Pharmacy Co., Ltd.
Division name
Kanagawa Branch
Zip code
100-0005
Address
Marunouchi Mitsui Building, 2-2-2 Marunouchi, Chiyoda-ku, Tokyo
TEL
03-3240-0222
sentaminami@aisei.co.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Nemoto |
Organization
Aisei Pharmacy Co., Ltd.
Division name
Kanagawa Branch
Zip code
100-0005
Address
Marunouchi Mitsui Building, 2-2-2 Marunouchi, Chiyoda-ku, Tokyo
TEL
03-3240-0222
Homepage URL
sentaminami@aisei.co.jp
Sponsor or person
Institute
Aisei Pharmacy Co., Ltd.
Institute
Department
Personal name
Shingo Nemoto
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aisei Pharmacy Ethics Review Committee
Address
Marunouchi Mitsui Building, 2-2-2 Marunouchi, Chiyoda-ku, Tokyo
Tel
03-3240-0222
sentaminami@aisei.co.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 01 | 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
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
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 |
Date of closure to data entry
| 2026 | Year | 04 | Month | 11 | Day |
Date trial data considered complete
| 2026 | Year | 04 | Month | 18 | Day |
Date analysis concluded
| 2026 | Year | 04 | Month | 25 | Day |
Other
Other related information
Fill in the tentative dates according to the input format of the UMIN registration format. In this study, the extracted data will be analyzed backward.
Management information
Registered date
| 2026 | Year | 03 | Month | 20 | Day |
Last modified on
| 2026 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069807
