UMIN-CTR Clinical Trial

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	Unpublished
Publication of results	Published

Result
URL related to results and publications	https://www.jstage.jst.go.jp/article/internalmedicine/60/3/60_5512-20/_article
Number of participants that the trial has enrolled	7754
Results	Bilateral foot pain symptoms were reported by 1,768/7,754 (22.8%) respondents.
Results date posted	2022 Year 06 Month 09 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	The majority of patients were male (88.4%), between 50 and 69 years of age (66.8%), with type 2 diabetes (92.5%), and were never or ex-smokers (72.8%). Overall, 22.3% of patients were diagnosed with diabetes in the last 5 years, while 27.2% were diagnosed over 15 years ago; the most recent HbA1c values for 54.3% of patients were less than 7.0%. The majority of patients had been treated in an internal medicine department (57.5%) and in a clinic (71.5%).
Participant flow	Of the 10,008 patients with diabetes mellitus who accessed the questionnaire, 8,930 (89.2%) agreed to participate in this study. Among the 7,754 (86.8%) patients meet the inclusion criteria.
Adverse events	not applicable
Outcome measures	Bilateral foot pain symptoms were reported by 1,768/7,754 (22.8%) respondents, most commonly intense numbness (13.0%). Of those with symptoms, 55.3% consulted a doctor; the most common reason for not seeking consultation was feeling that symptoms were insufficiently severe to bother their doctor (89.4%). Nearly 60% reported understanding the causes of their symptoms, with diabetes-associated neurologic deficits (58.8%). About one-quarter reported daily life problems, including an inability to walk for long periods (58.3%) and feeling anxious (58.1%). Treatment awareness was reported by 18.2%; oral medications were commonly recognized (64.6%).
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	2022 Year 06 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042166