Clinical Trials List
2015-03-01 - 2017-05-31
Phase III
Terminated17
ICD-10E08.42
Diabetes mellitus due to underlying condition with diabetic polyneuropathy
ICD-10E09.42
Drug or chemical induced diabetes mellitus with neurological complications with diabetic polyneuropathy
ICD-10E10.40
Type 1 diabetes mellitus with diabetic neuropathy, unspecified
ICD-10E10.42
Type 1 diabetes mellitus with diabetic polyneuropathy
ICD-10E11.40
Type 2 diabetes mellitus with diabetic neuropathy, unspecified
ICD-10E11.42
Type 2 diabetes mellitus with diabetic polyneuropathy
ICD-10E13.42
Other specified diabetes mellitus with diabetic polyneuropathy
ICD-9357.2
Polyneuropathy in diabetes
An Asian, Phase III, multicenter, randomized, double-blind, placebo-controlled, 14-week trial to evaluate the efficacy of DS-5565 in patients with diabetic peripheral neuropathy pain (DPNP), followed by a 52-week open period Mark the extension test.
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Trial Applicant
Daiichi Sankyo Taiwan Ltd.
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Sponsor
Daiichi Sankyo Co. Ltd
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
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The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
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The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
15
5
Endpoints
Average daily pain score
[Secondary Evaluation Index]
-Simplified McGill Pain Questionnaire
- safety
Inclution Criteria
- Suffer from type 1 or type 2 diabetes
- Distal symmetrical polyneuropathy with pain
- Average daily pain score ≥ 4 points
Exclusion Criteria
- Poor blood glucose control, diabetes treatment may need to be changed during the trial (non-insulin drug therapy, exercise therapy, diet therapy)
- Have other severe pain that is not related to diabetic peripheral neuropathy (DPN) and may confuse the evaluation of DPNP
- Have a neurological disorder that is not related to DPN and may confuse the evaluation of DPNP
The Estimated Number of Participants
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Taiwan
100 participants
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Global
750 participants
