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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000041981 |
Receipt No. | R000047897 |
Scientific Title | Satisfaction survey of diabetic patients treated for pain or numbness in the feet and legs (online questionnaire) |
Date of disclosure of the study information | 2020/10/02 |
Last modified on | 2021/01/22 |
Basic information | ||
Public title | Satisfaction survey of diabetic patients treated for pain or numbness in the feet and legs (online questionnaire) | |
Acronym | Satisfaction survey of diabetic patients treated for pain or numbness in the feet and legs (online questionnaire) | |
Scientific Title | Satisfaction survey of diabetic patients treated for pain or numbness in the feet and legs (online questionnaire) | |
Scientific Title:Acronym | Satisfaction survey of diabetic patients treated for pain or numbness in the feet and legs (online questionnaire) | |
Region |
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Condition | ||||
Condition | Diabetic peripheral neuropathic pain | |||
Classification by specialty |
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Classification by malignancy | Others | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To determine the level of satisfaction of diabetic patients treated for pain or numbness in the feet and legs. |
Basic objectives2 | Others |
Basic objectives -Others | Observational research
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Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Others |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Level of satisfaction of patients treated for painful feet and legs
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Key secondary outcomes | 1.Reason for the level of satisfaction with treatment of painful feet and legs
2.Level of communication with their physician 3.Level of improvement in daily activities after treatment of painful feet and legs 4.Level of improvement in quality of life (QOL) after treatment of painful feet and legs 5.Awareness of the cause of pain symptoms 6.Preference in pain treatment |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1.Patients receiving outpatient treatment of diabetes at the time of study enrollment
2.Patients having painful or numb feet and legs and consulting their physician about the symptom at the time of study enrollment 3.Age >=20years at the time of obtaining consent 4.Patients who are able to understand the study procedures, answer questions properly, and consent to study participation |
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Key exclusion criteria | Market research, advertising /marketing, media, healthcare workers, people involved in pharmaceutical companies
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Target sample size | 400 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |||||||
takatsuna.hiroshi.wb@daiichisankyo.co.jp |
Sponsor | |
Institute | DAIICHI SANKYO CO., LTD.
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Institute | |
Department |
Funding Source | |
Organization | DAIICHI SANKYO CO., LTD.
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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 | Kitamachi clinic |
Address | 1-1-3 Kitamachi, Musashino-city, Tokyo |
Tel | 070-5011-8550 |
shingo-namiki@cmicgroup.com |
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 |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047897 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |