UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033571 |
|---|---|
| Receipt number | R000038284 |
| Scientific Title | A comparative evaluation of effect of the combination of local anesthetics and capsaicin for neuropathic pain |
| Date of disclosure of the study information | 2021/12/31 |
| Last modified on | 2024/04/29 09:59:31 |
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Basic information
Public title
A comparative evaluation of effect of the combination of local anesthetics and capsaicin for neuropathic pain
Acronym
Effect of the combination of local anesthetics and capsaicin
Scientific Title
A comparative evaluation of effect of the combination of local anesthetics and capsaicin for neuropathic pain
Scientific Title:Acronym
Effect of the combination of local anesthetics and capsaicin
Region
| Japan |
Condition
Condition
Neuropathic pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A comparative evaluation of the combination of local anesthetics and capsaicin for neuropathic pain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS,NRS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
group of 0.5% lidocaine cream
Interventions/Control_2
group of 0.025% capsaicin cream
Interventions/Control_3
group of mixed cream containing 0.5% lidocaine and 0.0125% capsaicin cream
Interventions/Control_4
group of mixed cream containing 0.5% lidocaine and 0.005% capsaicin cream
Interventions/Control_5
group of mixed cream containing 0.5% lidocaine and 0.0025% capsaicin cream
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with neuropathic pain who were not satisfied with the treatment effect by block therapy or drug therapy
Key exclusion criteria
Patients with poor general condition
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Matsuki |
Organization
Department of Anesthesiology & Reanimatology, Faculty of Medical Sciences, University of Fukui, Fukui, Japan
Division name
Department of Anesthesiology & Reanimatology
Zip code
9190632
Address
23-3 Eiheijicho, Yoshidagun, Fukui 910-1193, Japan
TEL
09043787260
ymatsuki@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Matsuki |
Organization
Department of Anesthesiology & Reanimatology, Faculty of Medical Sciences, University of Fukui, Fuku
Division name
Department of Anesthesiology & Reanimatology
Zip code
910-1193
Address
23-3 Eiheijicho, Yoshidagun, Fukui 910-1193, Japan
TEL
0776618391
Homepage URL
ymatsuki@u-fukui.ac.jp
Sponsor or person
Institute
Department of Anesthesiology & Reanimatology, Faculty of Medical Sciences, University of Fukui, Fukui, Japan
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology & Reanimatology, Faculty of Medical Sciences, University of Fukui, Fukui, Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Anesthesiology and Pain Medicine, Hyogo College of Medicine, Hyogo, Japan
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Fukui, Faculty of Medicine Sciences, Fukui, Japan
Address
23-3 Eiheijicho, Yoshidagun, Fukui 910-1193, Japan
Tel
0776618529
rinsho-rinri@ml.u-fukui.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
| 2021 | Year | 12 | Month | 31 | 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
30
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
| 2017 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 31 | Day |
Last modified on
| 2024 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038284
