Unique ID issued by UMIN | UMIN000017130 |
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Receipt number | R000019085 |
Scientific Title | Single-arm open study to detect the sarrogate markers by functional brain imaging and electophisiological methods for the efficacy of the serotonin/noradrenaline re uptake inhibitor for the pain of diabetic polyneuropathy |
Date of disclosure of the study information | 2015/04/13 |
Last modified on | 2015/04/13 13:57:42 |
Single-arm open study to detect the sarrogate markers by functional brain imaging and electophisiological methods for the efficacy of the serotonin/noradrenaline re uptake inhibitor for the pain of diabetic polyneuropathy
Single-arm open study to detect the sarrogate markers by functional brain imaging and electophysiological methods for the efficacy of the
Single-arm open study to detect the sarrogate markers by functional brain imaging and electophisiological methods for the efficacy of the serotonin/noradrenaline re uptake inhibitor for the pain of diabetic polyneuropathy
Single-arm open study to detect the sarrogate markers by functional brain imaging and electophysiological methods for the efficacy of the
Japan |
Diabetic neuropathy
Neurology |
Others
NO
To investigate the measures of evaluation regarding efficacy of serotonin/noradrenaline re-uptake inhibitor for neuropathic pain due to diabetic neuropathy.
Others
To investigate the measures of evaluation regarding efficacy of serotonin/noradrenaline re-uptake inhibitor for neuropathic pain due to diabetic neuropathy.
Exploratory
Others
Not applicable
Cerebral blood flow measured by single photon emission computed tomography (whole brain analysis).
1) Cerebral blood flow measured by single photon emission computed tomography (region of interest analysis).
2) pain related somatosensory evoked potentials findings (amplitude, latencies, threshold, reaction time)
3) BPI(Brief pain inventory) 24h average pain severity score.
4) BPI ADL score.
5) SFMPQ
6) PHQ-9
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Duloxetin 60mg daily p.o.
20 | years-old | <= |
80 | years-old | > |
Male and Female
1) Patients diagnosed of type II diabetes
2) Patients complaining of neuropathic pain in the bilateral feet ( not includes only symptom of arms, coldness).
3) Possible to exclude other diagnoses which cause neuropathic pain.
4) More than 1 month duration of symptom.
5) Patients who meets more than 2 of 3 below:
i) neuropathic symptom of lower extremities (L/Es)
ii) Decreased sensation of distal part of L/Es.
iii) Decreased or absent tendon reflexes of L/Es.
6) Patients who meets more than 1 of 2 below:
i) Disturbance of ADL due to neuropathic pain
ii) More than 4 in the BPI 24h average pain score.
7) Age 20-80
8) Documented consent by the patient or substitutes
1) Patients taking duloxetine, pregabalin, carbamazepine, mexiletine, opioid, tramadol within 2 weeks before the registration.
2) Patients taking MAO inhibitors within 2 weeks prior to the registration.
3) Patients taking medications which have large effect to the cerebral blood flow.
4) Major blood sugar decrease within 4 weeks before registration.
5) Patients likely to experience major improvement of their blood sugar control.
6) History of drug abuse or addiction.
7) Patients with severe complications (cardiac failure, renal failure, hepatic failure, hemorrhagic peptic ulcers,bowel obstruction, malignant tumor, glaucoma.)
8) Pregnancy or desire to bear children.
9) Allergic history to duloxetine
10) History of treatment to depression, bipolar disorder, anxiety disorder, anorexia nervosa within 1 year prior to the registration.
11) MMSE less than 23.
12) Patients considered inappropriate by investigators.
20
1st name | |
Middle name | |
Last name | Sonoko Misawa |
Chiba university, Graduate school of medicine.
Department of neurology
1-8-1 Inohana Chuo-ku, Chiba-shi
043-222-7171
sonoko.m@mb.infoweb.ne.jp
1st name | |
Middle name | |
Last name | Keisuke Watanabe |
Chiba university, Graduate school of medicine.
Department of neurology
1-8-1 Inohana Chuo-ku, Chiba-shi
043-222-7171
ksuke0304@gmail.com
Chiba university, Graduate school of medicine.
SHIONOGI & CO., Ltd
Profit organization
NO
千葉大学医学部付属病院
2015 | Year | 04 | Month | 13 | Day |
Unpublished
Preinitiation
2015 | Year | 02 | Month | 06 | Day |
2015 | Year | 04 | Month | 01 | Day |
2015 | Year | 04 | Month | 13 | Day |
2015 | Year | 04 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019085
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