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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name