UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy and safety of Mirogabalin for chronic pain derived from neuropathic pain
Acronym	The efficacy and safety of Mirogabalin
Scientific Title	The efficacy and safety of Mirogabalin for chronic pain derived from neuropathic pain
Scientific Title:Acronym	The efficacy and safety of Mirogabalin
Region	Japan

Condition
Condition	Chronic pain, Neuropathic pain
Classification by specialty	Anesthesiology Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Patients who suffer chronic pain and neuropathic pain are prescribed Mirogabalin in our department. We observe its efficacy and side effects by use of questionnaires.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	NRS(Numerical rating scale) is assessed at, before perscription, in 2 weeks, and in 1/2/3/6 months.
Key secondary outcomes	Side effects and QOL scores are assessed, before perscription, in 2 weeks, and in 1/2/3/6 months.

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Chronic pain, Neuropathic pain
Key exclusion criteria	Patients who cannot answer questionnaires
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yoichiro Middle name Last name Abe
Organization	NTT Medical Center Tokyo
Division name	Pain clinic
Zip code	141-8625
Address	Higashigotanda 5-9-22, Shinagawa, Tokyo
TEL	03-3448-6111
Email	emiko.kawamura@east.ntt.co.jp

Public contact
Name of contact person	1st name Chiharu Middle name Last name Hayashi
Organization	NTT Medical Center Tokyo
Division name	Pain clinic
Zip code	141-8625
Address	Higashigotanda 5-9-22, Shinagawa, Tokyo
TEL	03-3448-6111
Homepage URL
Email	thousand.sunny.e.b.d@gmail.com

Sponsor
Institute	NTT Medical Center Tokyo Department of Pain clinic
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	NTT Medical Center Tokyo Ethics Committee
Address	Higashigotanda 5-9-22, Shinagawa, Tokyo
Tel	03-3448-6111
Email	hagihasg@gmail.com

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	NTT東日本関東病院(東京都）

Other administrative information
Date of disclosure of the study information	2019 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.jstage.jst.go.jp/article/jjspc/28/4/28_20-0035/_article/-char/ja/
Number of participants that the trial has enrolled	257
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 04 Month 21 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 06 Month 26 Day
Date of IRB	2019 Year 07 Month 01 Day
Anticipated trial start date	2019 Year 07 Month 01 Day
Last follow-up date	2020 Year 08 Month 31 Day
Date of closure to data entry	2020 Year 08 Month 31 Day
Date trial data considered complete	2020 Year 08 Month 31 Day
Date analysis concluded	2020 Year 09 Month 01 Day

Other
Other related information	We are following up not only NRS, but also side effects, EQ5D, HADS, PCS, and AIS.

Management information
Registered date	2019 Year 06 Month 30 Day
Last modified on	2021 Year 07 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042361