UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028993
Receipt number R000033122
Scientific Title Psychophysical and neuroimaging study on therapeutic effects of Neurotropin on pain
Date of disclosure of the study information 2017/09/04
Last modified on 2020/03/26 18:35:33

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Basic information

Public title

Psychophysical and neuroimaging study on therapeutic effects of Neurotropin on pain

Acronym

Neuroimaging of Neurotropin action

Scientific Title

Psychophysical and neuroimaging study on therapeutic effects of Neurotropin on pain

Scientific Title:Acronym

Neuroimaging of Neurotropin action

Region

Japan


Condition

Condition

Chronic pain

Classification by specialty

Anesthesiology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine therapeutic effects of Neurotropin on chronic pain using psychophysical measures of offset analgesia and multimodal magnetic resonance imaging.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. Indices of offset analgesia
2. Cerebral activation associated with offset analgesia
3. Cerebral functional and anatomical connectivity
4. Cerebral blood flow
5. Voxel-based morphometry

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

To administer 1 ampoule of Neurotropin intravenously in an acute manner to healthy controls.

Interventions/Control_2

To administer 1 ampoule of Neurotropin intravenously in an acute manner to patients with chronic pain.

Interventions/Control_3

To administer 4 tablets of Neurotropin per day orally for one month to healthy controls.

Interventions/Control_4

To administer 4 tablets of Neurotropin per day orally for one month to patients with chronic pain.

Interventions/Control_5


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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Patients with chronic pain with a numerical rating scale more than or equal to 3 for longer than 3 months.
2. Age- and gender-matched adults without any pain.

Key exclusion criteria

1. A person with known history of allergic reaction to Neurotropin.
2. A person with contraindications against MRI such as claustrophobia, pregnancy, pacemakers or metals in the body.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Jiro
Middle name
Last name Kurata

Organization

The Jikei University School of Medicine

Division name

Department of Anesthesiology

Zip code

105-8461

Address

3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo

TEL

03-3433-1111

Email

jkurata@plum.plala.or.jp


Public contact

Name of contact person

1st name Jiro
Middle name
Last name Kurata

Organization

The Jikei University School of Medicine

Division name

Department of Anesthesiology

Zip code

105-8461

Address

3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo

TEL

03-3433-1111

Homepage URL


Email

jkurata@plum.plala.or.jp


Sponsor or person

Institute

Department of Anesthesiology, the Jikei University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Nippon Zoki Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Ethics committee of The Jikei University School of Medicine for Biomedical Research

Address

3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo

Tel

03-3433-1111

Email

rinri@jikei.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

2017 Year 09 Month 04 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

Preinitiation

Date of protocol fixation

2017 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2020 Year 08 Month 01 Day

Last follow-up date

2030 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

2017 Year 09 Month 04 Day

Last modified on

2020 Year 03 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033122


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name