UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014908 |
|---|---|
| Receipt number | R000017340 |
| Scientific Title | Investigation of mechanisms of pain controlled by nerve growth factor in the peripheral blood |
| Date of disclosure of the study information | 2014/08/20 |
| Last modified on | 2023/01/02 09:39:36 |
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Basic information
Public title
Investigation of mechanisms of pain controlled by nerve growth factor in the peripheral blood
Acronym
Peripheral blood parameters and mechanisms of pain
Scientific Title
Investigation of mechanisms of pain controlled by nerve growth factor in the peripheral blood
Scientific Title:Acronym
Peripheral blood parameters and mechanisms of pain
Region
| Japan |
Condition
Condition
postoperative pain
chronic pain
cancer pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Investigation of associations between perioperative factors including parameters in the peripheral blood and perioperative pain or nociception.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Associations between perioperative factors including parameters in the peripheral blood and perioperative pain or nociception.
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
Diagnosis
Type of intervention
| Medicine | Gene | Device,equipment |
| Behavior,custom | Maneuver |
Interventions/Control_1
pain medicine
interventional pain therapy
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients under anesthetic management
patients under pain management
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Munetaka |
| Middle name | |
| Last name | Hirose |
Organization
Hyogo College of Medicine
Division name
Dept Anesthesiology and Pain Med
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL
0798-45-6392
mhirose@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Munetaka |
| Middle name | |
| Last name | Hirose |
Organization
Hyogo College of Medicine
Division name
Dept Anesthesiology and Pain Med
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL
0798-45-6392
Homepage URL
mhirose@hyo-med.ac.jp
Sponsor or person
Institute
Dept Anesthesiology and Pain Med, Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Hyogo College of Medicine
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
Tel
0798-45-6111
rinri@hyo-med.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
| 2014 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7034692/
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7034692/
Number of participants that the trial has enrolled
48
Results
Neuropathic pain characteristics are likely associated with methylation rates at the promoter region of the TRPA1 gene in human peripheral blood.
Results date posted
| 2023 | Year | 01 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Chronic pain patients and others.
Participant flow
Completed
Adverse events
None
Outcome measures
Associations between pain and DNA methylation in the blood.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 20 | Day |
Last modified on
| 2023 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017340
