UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045403 |
|---|---|
| Receipt number | R000051844 |
| Scientific Title | A Comparative Study of the Safety of Generic Alendronate Tablet Formulations Using Receipt Data |
| Date of disclosure of the study information | 2021/09/07 |
| Last modified on | 2024/04/17 20:14:10 |
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Basic information
Public title
A Comparative Study of the Safety of Generic Alendronate Tablet Formulations Using Receipt Data
Acronym
A Comparative Study of the Safety of Generic Alendronate Tablet Formulations Using Receipt Data
Scientific Title
A Comparative Study of the Safety of Generic Alendronate Tablet Formulations Using Receipt Data
Scientific Title:Acronym
A Comparative Study of the Safety of Generic Alendronate Tablet Formulations Using Receipt Data
Region
| Japan |
Condition
Condition
Upper gastrointestinal events
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the frequency of adverse drug reactions in the upper gastrointestinal tract in patients who used generic alendronate tablets and those who used the original drug, based on consultation, diagnosis, and dispensing information in the receipt database.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of patients diagnosed with upper gastrointestinal disease within 90 days of first dispensing alendronate tablets
Key secondary outcomes
Percentage of patients diagnosed with upper gastrointestinal disease within 90 days of first dispensing alendronate tablets
Percentage of patients whose prescriptions were discontinued within 90 days of an upper gastrointestinal event
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 with at least one oral claim for alendronic acid in the database
Key exclusion criteria
Patients who have information on the dispensing of oral bisphosphonates other than alendronate during the baseline period
Patients who have information on the preparation of bisphosphonates other than alendronate (including injectables) during the follow-up period
Target sample size
34000
Research contact person
Name of lead principal investigator
| 1st name | Takuhiro |
| Middle name | |
| Last name | Yamaguchi |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Biostatistics
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-Ku, Sendai-shi, Miyagi
TEL
022-717-7659
yamaguchi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Shih-Wei |
| Middle name | |
| Last name | Chiu |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Biostatistics
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-Ku, Sendai-shi, Miyagi
TEL
022-717-7659
Homepage URL
chiu@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Graduate School of Medicine
Address
1-1 Seiryo-machi, Aoba-Ku, Sendai-shi, Miyagi
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2021 | Year | 09 | Month | 07 | 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
9525
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Because additional analysis is needed.
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
By using the "JMDC Claims Database" provided by JMDC Co., Ltd., the diagnosis related to the upper gastrointestinal event described in the billing information when visiting a medical institution after the start of using alendronate is counted as the occurrence of side effects. Compare the incidence of upper gastrointestinal events between patients who used the original drug and those who used the generic drug
Management information
Registered date
| 2021 | Year | 09 | Month | 07 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051844
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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