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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000019634
Receipt No. 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

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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
Email 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
Email hkamiya@aichi-med-u.ac.jp

Sponsor
Institute Aichi Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022670

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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