UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053700 |
|---|---|
| Receipt number | R000060562 |
| Scientific Title | The elucidation for the modulation of endogenous pain inhibitory mechanism by drugs for the treatment of neuropathic pain |
| Date of disclosure of the study information | 2024/02/25 |
| Last modified on | 2024/02/25 17:12:16 |
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Basic information
Public title
The elucidation for the modulation of endogenous pain inhibitory mechanism by drugs for the treatment of neuropathic pain
Acronym
The elucidation for the modulation of endogenous pain inhibitory mechanism by drugs for the treatment of neuropathic pain
Scientific Title
The elucidation for the modulation of endogenous pain inhibitory mechanism by drugs for the treatment of neuropathic pain
Scientific Title:Acronym
The elucidation for the modulation of endogenous pain inhibitory mechanism by drugs for the treatment of neuropathic pain
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The elucidation for the modulation of endogenous pain inhibitory mechanism by drugs for the treatment of neuropathic pain
Basic objectives2
Others
Basic objectives -Others
The elucidation for the modulation of endogenous pain inhibitory mechanism by drugs for the treatment of neuropathic pain
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The evaluation of CPM effect before and after oral medication of the drugs for neuropathic pain.
CPM effect is evaluated by pressure pain threshold (PPT) before and during conditioning stimulus.
Key secondary outcomes
the modulation of QST (the Thermal Pain Illusion(TPI), Temporal Summation(TS), Offset Analgesia(OA) etc) and the effect of background (for example, psychology test including SDS, STAI, PCS etc), and the stress evaluated by catecholamine concentrations in plasma, urine and sweat.
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
Oral administration of pregabalin 150 mg, mirogabalin 15 mg, duloxetine 60 mg, amitriptyline 75 mg, vaccinia virus-inoculated rabbit inflamed skin extract 8 units, or lactose hydrate 2 tablets (control group). Each drug is administerd once on different days.
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
after informed consent is obtained, over 18 years old, healthy volunteers
Key exclusion criteria
the inability to give informed consent, under 18 years old, patients with a history of hypersensitivity to any of these ingredients, which is a contraindication to the administration of drugs of pregabalin, myrogabalin, duloxetine, amitriptyline, or vaccinia virus inoculated rabbit inflammatory skin extract,
patients on monoamine oxidase (MAO) inhibitors or within 2 weeks of discontinuation of MAO inhibitors, patients with severe hepatic dysfunction, angle-closure glaucoma, early recovery from myocardial infarction, or urinary retention (prostate disease, etc.), requiring caution in administration, acute intoxication with alcohol, sleeping pills, analgesics, opioid analgesics or psychotropic drugs, within 1 week after receiving or discontinuing nalmefene hydrochloride hydrate,
epilepsy not adequately controlled by treatment, renal dysfunction, severe congestive heart failure, elderly patients, history of angioedema, tendency or history of drug dependence, psychiatric disorders, pregnant women, and nursing mothers
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Oono |
Organization
Department of Diagnostic and Therapeutic Sciences, Meikai University School of Dentistry
Division name
Division of Dental Anesthesiology
Zip code
350-0283
Address
1-1, Keyakidai, Sakado-shi, Saitama
TEL
049-279-2738
yoono@dent.meikai.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Oono |
Organization
Department of Diagnostic and Therapeutic Sciences, School of Dentistry, Meikai University
Division name
Division of Dental Anesthesiology
Zip code
350-0283
Address
1-1, Keyakidai, Sakado-shi, Saitama
TEL
049-279-2738
Homepage URL
yoono@dent.meikai.ac.jp
Sponsor or person
Institute
Division of Dental Anesthesiology, Department of Diagnostic and Therapeutic Sciences, Meikai University School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Division of Dental Anesthesiology, Department of Diagnostic and Therapeutic Sciences, Meikai University School of Dentistry
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
Meikai University
Address
1-1, Keyakidai, Sakado-shi, Saitama
Tel
049-279-2712
kenkyu@dent.meikai.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
明海大学
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Tonic conditioning stimulus (CS) is applied to the forearm by quantitative thermal stimulator device (QTSD) with a pain intensity of 70 on VAS (0-100) for about 5 minutes. For CPM evaluation, pressure pain threshold (PPT) is measured at contralateral forearm before, during, and after CS.
Management information
Registered date
| 2024 | Year | 02 | Month | 25 | Day |
Last modified on
| 2024 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060562
