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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037023
Receipt No. R000042166
Scientific Title Actual Condition Survey Using Web Questionnaire for Diabetic Peripheral Neuropathic Pain Patients
Date of disclosure of the study information 2019/06/14
Last modified on 2019/08/28

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Basic information
Public title Actual Condition Survey Using Web Questionnaire for Diabetic Peripheral Neuropathic Pain Patients
Acronym Actual Condition Survey Using Web Questionnaire for Diabetic Peripheral Neuropathic Pain Patients
Scientific Title Actual Condition Survey Using Web Questionnaire for Diabetic Peripheral Neuropathic Pain Patients
Scientific Title:Acronym Actual Condition Survey Using Web Questionnaire for Diabetic Peripheral Neuropathic Pain Patients
Region
Japan

Condition
Condition Diabetic peripheral neuropathic pain
Classification by specialty
Medicine in general Endocrinology and Metabolism Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the actual condition of diabetic peripheral neuropathic pain patients.
Basic objectives2 Others
Basic objectives -Others Observational research
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes 1.The presence of symptoms of both feet
2.The following items about symptoms of both feet.

Consultation with a doctor, Understanding of the disease,
Burden in daily life,
Treatment awareness

Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients who are prescribed antidiabetic
(internal medicine, injection)
2.Patients who consent to participate in this study
3.Age >=20years at the time of obtaining consent
Key exclusion criteria Market research, advertising /marketing, media, healthcare workers, people involved in pharmaceutical companies
Target sample size 5500

Research contact person
Name of lead principal investigator
1st name Hisashi
Middle name
Last name Nakagaki
Organization DAIICHI SANKYO CO., LTD.
Division name Medical Science Department
Zip code 103-8426
Address 3-5-1 Nihonbashi Honcho Chuo-ku, Tokyo, 103-8426, Japan
TEL 03-6225-1053
Email nakagaki.hisashi.sh@daiichisankyo.co.jp

Public contact
Name of contact person
1st name Daiju
Middle name
Last name Matsui
Organization DAIICHI SANKYO CO., LTD.
Division name Medical Science Department
Zip code 103-8426
Address 3-5-1 Nihonbashi Honcho Chuo-ku, Tokyo, 103-8426, Japan
TEL 03-6225-1053
Homepage URL
Email matsui.daiju.ks@daiichisankyo.co.jp

Sponsor
Institute DAIICHI SANKYO CO., LTD.
Institute
Department

Funding Source
Organization DAIICHI SANKYO 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 Clinical research promotion network japan
Address 1-4-9,Itachibori, Nishi-ku, Osaka, Japan
Tel 06-4393-8403
Email osaka@sct-net.org

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 該当なし

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 14 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 Completed
Date of protocol fixation
2019 Year 05 Month 31 Day
Date of IRB
2019 Year 05 Month 23 Day
Anticipated trial start date
2019 Year 06 Month 17 Day
Last follow-up date
2019 Year 06 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Web Questionnaire Study of Diabetic Peripheral Neuropathic Pain

Management information
Registered date
2019 Year 06 Month 11 Day
Last modified on
2019 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042166

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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