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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047771
Receipt No. 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

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Basic information
Public title Investigation of the association between proton pump inhibitors and risk of adverse drug reactions using the Japanese medical database.
Acronym Investigation of the association between proton pump inhibitors and risk of adverse drug reactions using the Japanese medical database.
Scientific Title Investigation of the association between proton pump inhibitors and risk of adverse drug reactions using the Japanese medical database.
Scientific Title:Acronym Investigation of the association between proton pump inhibitors and risk of adverse drug reactions using the Japanese medical database.
Region
Japan

Condition
Condition drug-induced renal dysfunction
Classification by specialty
Medicine in general Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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).
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes chronic kidney disease
Key secondary outcomes 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

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients started on regular prescriptions (more than 1 month) for PPIs or H2 blockers
Key exclusion criteria Patients diagnosed with an adverse effect disease within 1 year prior to the index date when they started taking PPIs and H2 blockers
Target sample size 0

Research contact person
Name of lead principal investigator
1st name Tatsuya
Middle name
Last name Yagi
Organization Hamamatsu University School of Medicine
Division name Department of Hospital pharmacy
Zip code 431-3192
Address 1-20-1 Handayama, Hamamatsu, Shizuoka, Japan
TEL 053-435-2767
Email yagi5922@hama-med.ac.jp

Public contact
Name of contact person
1st name Hironari
Middle name
Last name Tanaka
Organization Hamamatsu University School of Medicine
Division name Department of Hospital pharmacy
Zip code 431-3192
Address 1-20-1 Handayama, Hamamatsu, Shizuoka, Japan
TEL 053-435-2767
Homepage URL
Email htanaka@hama-med.ac.jp

Sponsor
Institute Department of Hospital pharmacy
Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Department of Hospital pharmacy
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor University of Shizuoka
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee of Clinical Research
Address 1-20-1 Handayama, Hamamatsu, Shizuoka, Japan
Tel 053-435-2680
Email rinri@hama-med.ac.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
2022 Year 05 Month 17 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
2021 Year 11 Month 15 Day
Date of IRB
2022 Year 01 Month 11 Day
Anticipated trial start date
2022 Year 01 Month 11 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 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.

Management information
Registered date
2022 Year 05 Month 16 Day
Last modified on
2022 Year 05 Month 16 Day


Link to view the page
URL(English) 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


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