UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037216 |
|---|---|
| Receipt number | R000042361 |
| Scientific Title | The efficacy and safety of Mirogabalin for chronic pain derived from neuropathic pain |
| Date of disclosure of the study information | 2019/07/01 |
| Last modified on | 2021/07/18 08:58:44 |
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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
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
thousand.sunny.e.b.d@gmail.com
Sponsor or person
Institute
NTT Medical Center Tokyo
Department of Pain clinic
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
NTT Medical Center Tokyo Ethics Committee
Address
Higashigotanda 5-9-22, Shinagawa, Tokyo
Tel
03-3448-6111
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042361
