UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036855 |
|---|---|
| Receipt number | 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 12:50:19 |
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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
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
hiromif@ktd.biglobe.ne.jp
Sponsor or person
Institute
Kajiki Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041987
