UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017130
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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Chiba university, Graduate school of medicine.

Institute

Department

Personal name



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

Value
https://center6.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