UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001662 |
|---|---|
| Receipt number | R000002007 |
| Scientific Title | Epalrestat effect on diabetic neuropathy in primary care setting |
| Date of disclosure of the study information | 2009/01/28 |
| Last modified on | 2010/07/27 09:58:18 |
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Basic information
Public title
Epalrestat effect on diabetic neuropathy in primary care setting
Acronym
Epalrestat effect on diabetic neuropathy in primary care setting
Scientific Title
Epalrestat effect on diabetic neuropathy in primary care setting
Scientific Title:Acronym
Epalrestat effect on diabetic neuropathy in primary care setting
Region
| Japan |
Condition
Condition
diabetic neuropathy
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to confirm the efficacy of epalrestat on diabetic neuropathy by 1-year long periodical observation of primary care setting.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
symptom score of patient questionnaire
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
treatment by epalrestat
Interventions/Control_2
observation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patient with diabetic neuropathy and written informed consent obtained
Key exclusion criteria
not specified
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kondo Kunio |
Organization
Ishikawa Medical Association
Division name
Ishikawa Internal Medicine Association
Zip code
Address
2-48 Kuratsuki-higashi, Kanazawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Ishikawa Medical Association
Division name
Ishikawa Internal Medicine Association
Zip code
Address
TEL
Homepage URL
inano-heart@bpost.plala.or.jp
Sponsor or person
Institute
Ishikawa Internal Medicine Association
Institute
Department
Personal name
Funding Source
Organization
Ishikawa Internal Medicine Association
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2009 | Year | 01 | Month | 28 | 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
| 2008 | Year | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 01 | Month | 27 | Day |
Last modified on
| 2010 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002007
