UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042592 |
|---|---|
| Receipt number | R000048501 |
| Scientific Title | Study on real-world prescription of mirogabalin besilate using the pharmacy claims database |
| Date of disclosure of the study information | 2020/12/01 |
| Last modified on | 2021/12/21 12:49:05 |
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Basic information
Public title
Study on real-world prescription of mirogabalin besilate using the pharmacy claims database
Acronym
Study on real-world prescription of mirogabalin besilate
Scientific Title
Study on real-world prescription of mirogabalin besilate using the pharmacy claims database
Scientific Title:Acronym
Study on real-world prescription of mirogabalin besilate
Region
| Japan |
Condition
Condition
Pain
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine how mirogabalin besilate, a new drug for the treatment of peripheral neuropathic pain, is prescribed in the real-world setting
Basic objectives2
Others
Basic objectives -Others
Observational Study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of patients prescribed mirogabalin besilate
Key secondary outcomes
1) Starting dose of mirogabalin besilate and changes in prescribed daily dose over time
2) Maintenance dose of mirogabalin besilate
3) Total and mean prescribed doses of mirogabalin besilate
4) Percentage of patients receiving oral analgesics in combination with mirogabalin besilate by co-administration pattern
5) Medication possession ratio (MPR) of mirogabalin besilate
6) Percentage of patients discontinuing mirogabalin besilate therapy
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 having prescriptions filled at Japanese insurance pharmacies operating under an agreement with the contract research organization between June 1, 2020 and August 31, 2020 and prescribed mirogabalin besilate
Key exclusion criteria
Patients prescribed mirogabalin besilate within 180 days before the first prescription
Target sample size
13000
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Okuizumi |
Organization
DAIICHI SANKYO CO., LTD.
Division name
Medical Science Department
Zip code
103-8426
Address
3-5-1 Nihonbashi Honcho Chuo-ku, Tokyo
TEL
03-6225-1053
okuizumi.kaoru.tr@daiichisankyo.co.jp
Public contact
Name of contact person
| 1st name | Mizuka |
| Middle name | |
| Last name | Yokoyama |
Organization
DAIICHI SANKYO CO., LTD.
Division name
Medical Science Department
Zip code
103-8426
Address
3-5-1 Nihonbashi Honcho Chuo-ku, Tokyo
TEL
03-6225-1053
Homepage URL
yokoyama.mizuka.j2@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
N/A
Address
N/A
Tel
N/A
N/A
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
| 2020 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.tandfonline.com/doi/full/10.1080/14656566.2021.2007239
Number of participants that the trial has enrolled
12924
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
| 2020 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Database study on oral analgesic agent.
This is a study that has not been deliberated by the Ethics Review Committee.
Management information
Registered date
| 2020 | Year | 11 | Month | 30 | Day |
Last modified on
| 2021 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048501
