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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036855
Receipt No. R000041987
Scientific Title The efficacy and safety of mirogabalin for neuropathic pain
Date of disclosure of the study information 2019/06/01
Last modified on 2019/05/26

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Basic information
Public title The efficacy and safety of mirogabalin for neuropathic pain
Acronym The efficacy and safety of mirogabalin for neuropathic pain
Scientific Title The efficacy and safety of mirogabalin for neuropathic pain
Scientific Title:Acronym The efficacy and safety of mirogabalin for neuropathic pain
Region
Japan

Condition
Condition neuropathic pain
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish the efficacy and safety of mirogabalin for neurptahic pain
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Visual analogue scale (VAS) is assessed before, and, 1 week, 2 weeks, 1 month, 2 months, 3 months,6 months, 1 year after drug administration
Key secondary outcomes

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria neuropathic apin
Key exclusion criteria can not be self-assessment of pain
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hiromi
Middle name
Last name Fujii
Organization Kajiki Hospital
Division name Anesesiology
Zip code 701-0136
Address 1231-1 Nishihanajiri Kita-ku, Okayama
TEL 086-293-3355
Email hiromif@ktd.biglobe.ne.jp

Public contact
Name of contact person
1st name Hiromi
Middle name
Last name Fujii
Organization Kajiki Hospital
Division name Anesthesiology
Zip code 701-0136
Address 1231-1 Nishihanajiri Kita-ku, Okayama
TEL 086-293-3355
Homepage URL https://kajikihp.or.jp
Email hiromif@ktd.biglobe.ne.jp

Sponsor
Institute Kajiki Hospital
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 Kajiki Hospital Ethics Committee
Address 1231-1 Nishihanajiri Kita-ku, Okayama
Tel 086-293-3355
Email Kajiki-hp@tiara.ocn.ne.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
2019 Year 06 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 Open public recruiting
Date of protocol fixation
2019 Year 05 Month 01 Day
Date of IRB
2019 Year 05 Month 20 Day
Anticipated trial start date
2019 Year 05 Month 01 Day
Last follow-up date
2021 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2019 Year 05 Month 26 Day
Last modified on
2019 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041987

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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