UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037023 |
|---|---|
| Receipt number | 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 | 2022/06/09 15:38:10 |
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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
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
matsui.daiju.ks@daiichisankyo.co.jp
Sponsor or person
Institute
DAIICHI SANKYO CO., LTD.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042166
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