UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019634 |
|---|---|
| Receipt number | R000022670 |
| Scientific Title | A Randomized, Single-center, Parallel-group, Prospective Trial of Neuroprotective Effect of Epalrestat for Treatment of Diabetic Polyneuropathy. |
| Date of disclosure of the study information | 2015/11/04 |
| Last modified on | 2021/02/03 10:08:46 |
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Basic information
Public title
A Randomized, Single-center, Parallel-group, Prospective Trial of Neuroprotective Effect of Epalrestat for Treatment of Diabetic Polyneuropathy.
Acronym
Treatment of Diabetic Poluneuropathy With Epalrestat
Scientific Title
A Randomized, Single-center, Parallel-group, Prospective Trial of Neuroprotective Effect of Epalrestat for Treatment of Diabetic Polyneuropathy.
Scientific Title:Acronym
Treatment of Diabetic Poluneuropathy With Epalrestat
Region
| Japan |
Condition
Condition
Diabetic Polyneuropathy
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Neurology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate corneal confocal microscopic findings on treatment with epalrestat in patients with diabetic polyneuropathy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Change from screening in corneal confocal microscopic findings at month 36
2. Change from screening in nerve conduction studies at month 36
Key secondary outcomes
1. Score of Michigan Neuropathy Screening Instrument(MNSI)
2. Clinical findings: i) Absent or hypoactive Achilles tendon reflexes, ii) Impaired vibration sensation
3. HbA1c, blood glucose
4. Coefficients of variance of RR intervals
5. Diabetic nephropathy, Diabetic retinopathy
6. Laboratory data, blood pressure
7. safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Epalrestat, 150mg/day, 3 years
Interventions/Control_2
Control
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
Correspond to all of the following in recruitment of participants with type 2 diabetes:
1. HbA1c <= 9.0%
2. Diabetes treatment including diet therapy, exercise therapy, medication, and insulin therapy
3. Patients who meets more than 2 of 3 below:
i) Bilateral neuropathic symptom of lower extremities
ii) Bilateral decreased vibration sensation of lower extremities
iii) Bilateral decrease or absence of Achilles tendon reflexes.
Key exclusion criteria
1. Pregnancy, lactation
2. Type 1 diabetes, othertypes of diabetes
3. Past history of diabetic ketoacidosis
4. Severe infection, Pre-/post-operation, Severe injuries
5. Treatment with steroids
6. Current/Past malignancy
7. Inappropriate patients for entry on this study in the judgement of the investigator
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Jiro |
| Middle name | |
| Last name | Nakamura |
Organization
Aichi Medical University
Division name
Diabetes
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi 480-1195
TEL
0561-63-1683
jiro@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Kamiya |
Organization
Aichi Medical University
Division name
Diabetes
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi 480-1195
TEL
0561-63-1683
Homepage URL
hkamiya@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Division of Diabetes, Department of Internal Medicine, Aichi Medical University
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
Aichi Medical University School of Medicine
Address
1-1 Yazakokarimata, Nagakute, Aichi 480-1195
Tel
0561-63-1683
thimeno@aichi-med-u.ac.jp
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
| 2015 | Year | 11 | Month | 04 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 04 | Day |
Last modified on
| 2021 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022670
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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