Unique ID issued by UMIN | UMIN000047771 |
---|---|
Receipt number | R000054453 |
Scientific Title | Investigation of the association between proton pump inhibitors and risk of adverse drug reactions using the Japanese medical database. |
Date of disclosure of the study information | 2022/05/17 |
Last modified on | 2022/05/16 01:11:02 |
Investigation of the association between proton pump inhibitors and risk of adverse drug reactions using the Japanese medical database.
Investigation of the association between proton pump inhibitors and risk of adverse drug reactions using the Japanese medical database.
Investigation of the association between proton pump inhibitors and risk of adverse drug reactions using the Japanese medical database.
Investigation of the association between proton pump inhibitors and risk of adverse drug reactions using the Japanese medical database.
Japan |
drug-induced renal dysfunction
Medicine in general | Nephrology |
Others
NO
Using a Japanese population database, the purpose of this study is to examine whether the dose and duration of PPI use increases the risk of developing or progressing to renal dysfunction and other adverse effects compared to those not taking PPIs or those using other acid suppression treatments (H2 blockers).
Safety
chronic kidney disease
Adverse events such as acute interstitial nephritis (AIN), Clostridioides difficile enteritis
Changes in the onset of adverse effects with the type and dose of PPIs and H2 blockers
Changes in the incidence of adverse effects in each group by propensity score matching
Observational
Not applicable |
Not applicable |
Male and Female
Patients started on regular prescriptions (more than 1 month) for PPIs or H2 blockers
Patients diagnosed with an adverse effect disease within 1 year prior to the index date when they started taking PPIs and H2 blockers
0
1st name | Tatsuya |
Middle name | |
Last name | Yagi |
Hamamatsu University School of Medicine
Department of Hospital pharmacy
431-3192
1-20-1 Handayama, Hamamatsu, Shizuoka, Japan
053-435-2767
yagi5922@hama-med.ac.jp
1st name | Hironari |
Middle name | |
Last name | Tanaka |
Hamamatsu University School of Medicine
Department of Hospital pharmacy
431-3192
1-20-1 Handayama, Hamamatsu, Shizuoka, Japan
053-435-2767
htanaka@hama-med.ac.jp
Department of Hospital pharmacy
Hamamatsu University School of Medicine
Department of Hospital pharmacy
Hamamatsu University School of Medicine
Self funding
University of Shizuoka
Ethics Committee of Clinical Research
1-20-1 Handayama, Hamamatsu, Shizuoka, Japan
053-435-2680
rinri@hama-med.ac.jp
NO
2022 | Year | 05 | Month | 17 | Day |
Unpublished
Preinitiation
2021 | Year | 11 | Month | 15 | Day |
2022 | Year | 01 | Month | 11 | Day |
2022 | Year | 01 | Month | 11 | Day |
2024 | Year | 03 | Month | 31 | Day |
A cohort study using a Japanese database
No formal sample size calculation was conducted for the present study due to the nature of database study.
2022 | Year | 05 | Month | 16 | Day |
2022 | Year | 05 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054453
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |