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
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
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
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
