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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042592
Receipt No. 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 2020/11/30

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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
Email 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
Email yokoyama.mizuka.j2@daiichisankyo.co.jp

Sponsor
Institute DAIICHI SANKYO CO., LTD.
Institute
Department

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
Email 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 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
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
2020 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048501

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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