UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045199 |
|---|---|
| Receipt number | R000051391 |
| Scientific Title | Influence of acetaminophen on liver function: A cohort study using a real world database |
| Date of disclosure of the study information | 2021/08/20 |
| Last modified on | 2023/02/27 09:32:34 |
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Basic information
Public title
Influence of acetaminophen on liver function: A cohort study using a real world database
Acronym
Influence of acetaminophen on liver function: A cohort study using a real world database
Scientific Title
Influence of acetaminophen on liver function: A cohort study using a real world database
Scientific Title:Acronym
Influence of acetaminophen on liver function: A cohort study using a real world database
Region
| Japan |
Condition
Condition
Drug-induced liver injury
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate hepatic damage caused by medium- to long-term usege of acetaminophen(APAP) compared with NSAIDs
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence rates of hepatic disease and ALT > male 126U/L,female 69U/L(JCOG>3*ULN).
Non-inferiority of acetaminophen to NSAIDs with respect to risk of hepatotoxicity will be considered to be demonstrated if the 95% confidence interval of rate ratio below the non-inferiority margin of 1.39. This margin was set using a fixed-margin method based on a meta-analysis of randomized placebo-controlled trials.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have been prescribed either oral acetaminophen or NSAIDs (loxoprofen/celecoxib) for 28 consecutive days or longer
Key exclusion criteria
Patients with virus hepatitis (B15-B19), alcoholic hepatitis (K70), or a hepatic disorder name defined as a clinical outcome
Target sample size
0
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Okamoto |
Organization
AYUMI PHARMACEUTICAL CO., LTD
Division name
Medical Affairs Div.
Zip code
104-0061
Address
12-15 Ginza 4-Chome, Chuo-ku, Tokyo 104-0061, Japan
TEL
03-6264-3530
masahiro.okamoto@ayumi-pharma.com
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Okamoto |
Organization
AYUMI PHARMACEUTICAL CO., LTD
Division name
Medical Affairs Div.
Zip code
104-0061
Address
12-15 Ginza 4-Chome, Chuo-ku, Tokyo 104-0061, Japan
TEL
0362643530
Homepage URL
masahiro.okamoto@ayumi-pharma.com
Sponsor or person
Institute
AYUMI PHARMACEUTICAL CO., LTD
Institute
Department
Personal name
Funding Source
Organization
AYUMI PHARMACEUTICAL CO., LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Institute of Healthcare Data Science
Address
Sumitomosibadaimon Bld.12F,2-5-5, Shibadaimon. Minato-ku, Tokyo,Japan
Tel
03-5733-5010
rihds@jmdc.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
| 2021 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
34684
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
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | 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 healthcare database
No formal sample size calculation was conducted for the present study due to the nature of database study.
Management information
Registered date
| 2021 | Year | 08 | Month | 19 | Day |
Last modified on
| 2023 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051391
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
