UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020876 |
|---|---|
| Receipt number | R000024044 |
| Scientific Title | The investigation of norepinephrine/serotonin transporter in patients with painful diabetic neuropathy |
| Date of disclosure of the study information | 2016/02/04 |
| Last modified on | 2017/11/09 16:16:21 |
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Basic information
Public title
The investigation of norepinephrine/serotonin transporter in patients with painful diabetic neuropathy
Acronym
The investigation of norepinephrine/serotonin transporter in patients with painful diabetic neuropathy
Scientific Title
The investigation of norepinephrine/serotonin transporter in patients with painful diabetic neuropathy
Scientific Title:Acronym
The investigation of norepinephrine/serotonin transporter in patients with painful diabetic neuropathy
Region
| Japan |
Condition
Condition
Painful diabetic neuropathy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate a relationship between painful diabetic neuropathy and norepinephrine/serotonin transmission in the brain
Basic objectives2
Others
Basic objectives -Others
To investigate a relationship between painful diabetic neuropathy and norepinephrine/serotonin transmission in the brain
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The relationship between painful diabetic neuropathy and binding potentials of norepinephrine/serotonin transporter in the brain
Key secondary outcomes
The occupancy of norepinephrine/serotonin transporter, therapeutic effect, fMRI, cognitive function, physiological/psychological index
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Medication of duroxetine
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Diabetic neuropathy
Patients who were diagnosed type 2 diabetes mellitus
･Patients complaining of neuropathic pain in the bilateral feet ( not includes only symptom of arms, coldness).
･Patients excluded other diagnoses which cause neuropathic pain.
･Patients with more than one month duration of symptom.
･Patients who understand written informed consent.
Healthy individuals
･Persons with no history of mental diseases.
･Persons with no history of diabete mellitus and other serious physical diseases.
･Persons who understand written informed consent.
Key exclusion criteria
Diabetic neuropathy
･Patients taking pregabalin, carbamazepine, mexiletine within a weeks from registration.
･Patients taking monoamine oxidase inhibitor within two weeks from registration.
･Patients who showed a significant glycemic improvement by the treatment within four weeks from registration.
･Patients who are likely to experience significant glycemic improvement during the test period.
･Patients who are likely to require hospitalizations due to poor glycemic control.
･Patients with the involvement of alcoholic neuropathy.
･Patients with history of drug abuse or addiction.
･Patients with severe complications (cardiac failure, renal failure, hepatic failure, hemorrhagic peptic ulcers,bowel obstruction, malignant tumor, glaucoma.)
･Patients with pregnancy or desire to bear children.
･Patients with allergic history to duloxetine
･Patients who have metalic implants(cardiac pacemaker, intracephalic aneurysm clip, bolts, etc).
･Patients with strong claustrophobia
･Patients with history of treatment to depression, bipolar disorder, anxiety disorder, anorexia nervosa within one year prior to the registration.
･Patients corresponding to both of PHQ-2, or PHQ-9 score >15.
Patients considered inappropriate by investigators
Healthy individuals
･Persons with pregnancy or desire to bear children.
･Persons who have metalic implants(cardiac pacemaker, intracephalic aneurysm clip, bolts, etc).
･Persons with strong claustrophobia
･Patients within 6 months after the last injection of radioisotopes
･Patients considered inappropriate by investigators
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makiko Yamada |
Organization
National Institute of Radiological Sciences
Division name
Molecular Imaging Center
Zip code
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
043-206-3251
myamada@nirs.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuko Suzuki |
Organization
National Institute of Radiological Sciences
Division name
Molecular Imaging Center
Zip code
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
043-206-3025
Homepage URL
khsuzuki@nirs.go.jp
Sponsor or person
Institute
National Institute of Radiological Sciences
Institute
Department
Personal name
Funding Source
Organization
National Institute of Radiological Sciences
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 02 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 06 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 04 | Day |
Last modified on
| 2017 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024044
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