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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000017130
Receipt No. 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

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Basic information
Public 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
Acronym Single-arm open study to detect the sarrogate markers by functional brain imaging and electophysiological methods for the efficacy of the
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
Scientific Title:Acronym Single-arm open study to detect the sarrogate markers by functional brain imaging and electophysiological methods for the efficacy of the
Region
Japan

Condition
Condition Diabetic neuropathy
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the measures of evaluation regarding efficacy of serotonin/noradrenaline re-uptake inhibitor for neuropathic pain due to diabetic neuropathy.
Basic objectives2 Others
Basic objectives -Others To investigate the measures of evaluation regarding efficacy of serotonin/noradrenaline re-uptake inhibitor for neuropathic pain due to diabetic neuropathy.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Cerebral blood flow measured by single photon emission computed tomography (whole brain analysis).
Key secondary outcomes 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


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 Treatment
Type of intervention
Medicine
Interventions/Control_1 Duloxetin 60mg daily p.o.
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 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
Key exclusion criteria 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.

Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sonoko Misawa
Organization Chiba university, Graduate school of medicine.
Division name Department of neurology
Zip code
Address 1-8-1 Inohana Chuo-ku, Chiba-shi
TEL 043-222-7171
Email sonoko.m@mb.infoweb.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keisuke Watanabe
Organization Chiba university, Graduate school of medicine.
Division name Department of neurology
Zip code
Address 1-8-1 Inohana Chuo-ku, Chiba-shi
TEL 043-222-7171
Homepage URL
Email ksuke0304@gmail.com

Sponsor
Institute Chiba university, Graduate school of medicine.
Institute
Department

Funding Source
Organization SHIONOGI & CO., Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 千葉大学医学部付属病院

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 13 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
2015 Year 02 Month 06 Day
Date of IRB
Anticipated trial start date
2015 Year 04 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
2015 Year 04 Month 13 Day
Last modified on
2015 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019085

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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