UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049287 |
|---|---|
| Receipt number | R000056129 |
| Scientific Title | Pain-Related Evoked Potentials to Nociceptive Stimuli by Application of TRP Channel Agents |
| Date of disclosure of the study information | 2022/11/30 |
| Last modified on | 2024/10/22 10:08:54 |
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Basic information
Public title
Pain-Related Evoked Potentials to Nociceptive Stimuli by Application of TRP Channel Agents
Acronym
Pain-Related Evoked Potentials to Nociceptive Stimuli by Application of TRP Channel Agents
Scientific Title
Pain-Related Evoked Potentials to Nociceptive Stimuli by Application of TRP Channel Agents
Scientific Title:Acronym
Pain-Related Evoked Potentials to Nociceptive Stimuli by Application of TRP Channel Agents
Region
| Japan |
Condition
Condition
healty subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate that the effect of TRP channel agonist on pain-related evoked potentials.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analgesia effects of TRPchannls agonist.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Application menthol,
10% of Menthol solution,
20 minutes application.
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
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
Skin hypersensitivity disease,
Neuropathic disease
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Taiki |
| Middle name | |
| Last name | Makibuchi |
Organization
Niigata University of Health and Welfare
Division name
Field of Health and Sports
Zip code
950-3198
Address
Niigata 950-3198, Japan
TEL
070-2621-6054
wtm22005@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Koya |
| Middle name | |
| Last name | Yamashiro |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Sports
Zip code
950-3198
Address
Niigata 950-3198, Japan
TEL
025-257-4757
Homepage URL
yamashiro@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
Niigata 950-3198, Japan
Tel
025-257-4500
wtm22005@nuhw.ac.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
| 2022 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
25
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
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 03 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2024 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 21 | Day |
Last modified on
| 2024 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056129
