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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name