UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047313 |
|---|---|
| Receipt number | R000053961 |
| Scientific Title | A database study on the relationship between the dose titration pattern of mirogabalin prescription and adherence in patients with peripheral neuropathic pain |
| Date of disclosure of the study information | 2022/03/31 |
| Last modified on | 2023/02/14 10:20:56 |
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Basic information
Public title
A database study on the real-world prescription status of mirogabalin in patients with peripheral neuropathic pain
Acronym
A database study on the real-world prescription status of mirogabalin in patients with peripheral neuropathic pain
Scientific Title
A database study on the relationship between the dose titration pattern of mirogabalin prescription and adherence in patients with peripheral neuropathic pain
Scientific Title:Acronym
A database study on the real-world prescription status of mirogabalin in patients with peripheral neuropathic pain
Region
| Japan |
Condition
Condition
Peripheral neuropathic pain
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the real-world dose titration pattern of mirogabalin besylate (mirogabalin) in patients with peripheral neuropathic pain and to explore the relationship with their adherence.
Basic objectives2
Others
Basic objectives -Others
Investigation of the real-world prescription pattern of the drug
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Medical possession ratio (MPR)
Key secondary outcomes
Proportion of days covered (PDC)
Mirogabalin prescription continuation rate
Rate of switching to other peripheral neuropathic pain drugs
Prescription pattern of mirogabalin and other concomitant peripheral neuropathic pain drugs
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
1.Patients who were prescribed mirogabalin between March 1, 2020 and May 31, 2021
2.Patients with the diagnosis of peripheral neuropathic pain between the starting point and the index date on the database
3.Patients who were prescribed mirogabalin at least once within 45 days after the first prescription date
Key exclusion criteria
Patients who were prescribed mirogabalin at least once between the starting point and the first prescription date on the database
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Kimura |
| Middle name | |
| Last name | Tetsuya |
Organization
DAIICHI SANKYO CO., LTD.
Division name
Primary Medical Science Department
Zip code
103-8426
Address
3-5-1 Nihonbashi Honcho Chuo-ku, Tokyo
TEL
03-6225-1053
kimura.tetsuya.d2@daiichisankyo.co.jp
Public contact
Name of contact person
| 1st name | Kodama |
| Middle name | |
| Last name | Sho |
Organization
DAIICHI SANKYO CO., LTD.
Division name
Primary Medical Science Department
Zip code
103-8426
Address
3-5-1 Nihonbashi Honcho Chuo-ku, Tokyo
TEL
03-6225-1053
Homepage URL
kodama.sho.vc@daiichisankyo.co.jp
Sponsor or person
Institute
DAIICHI SANKYO CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO 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
Sumitomo Shiba Daimon Building 12F 2-5-5,Shiba-Daimon, Minato-ku, Tokyo 105-0012, 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
| 2022 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1080/14656566.2022.2155048
Number of participants that the trial has enrolled
4138
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
| 2022 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 03 | Month | 29 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 17 | Day |
Other
Other related information
This is a pharmacoepidemiological study aimed at describing the dose titration pattern of mirogabalin in patients with peripheral neuropathic pain who take the drug and exploring the relationship with their adherence, using an existing medical information database.
Management information
Registered date
| 2022 | Year | 03 | Month | 29 | Day |
Last modified on
| 2023 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053961
