Asian Phase 2 Study for Treatment of Pain Associated With Diabetic Peripheral Neuropathy

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effectiveness and safety of DS-5565, compared to placebo, in subjects with pain associated with diabetic peripheral neuropathy.

Official Title
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An Asian, Phase 2, Multicenter, Randomized, Double-blind, Placebo- and Pregabalin-controlled, Dose-finding Study of DS-5565 in Patients With Pain Associated With Diabetic Peripheral Neuropathy

Conditions
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Pain, Diabetic Peripheral Neuropathy

Intervention / Treatment
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* Drug: DS-5565
* Drug: DS-5565
* Drug: DS-5565
* Drug: Placebo
* Drug: Pregabalin capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 or Type 2 diabetes mellitus Painful distal symmetric polyneuropathy Average daily pain score is great than or equal to 4 Exclusion Criteria: HbA1c greater than 9.0

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DS-5565 Low Dose<br>DS-5565 10mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose. | Drug: DS-5565<br>* Oral tablets administered twice daily<br>|
| Experimental: DS-5565 Middle Dose<br>DS-5565 20mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose. | Drug: DS-5565<br>* Oral tablets administered twice daily<br>|
| Experimental: DS-5565 High Dose<br>DS-5565 30mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose. | Drug: DS-5565<br>* Oral tablets administered twice daily<br>|
| Placebo Comparator: Placebo<br>DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day. | Drug: Placebo<br>* DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day<br>|
| Active Comparator: Pregabalin<br>Pregabalin capsules 300mg/day administered in 2 doses | Drug: Pregabalin capsules<br>* Pregabalin oral capsules 150 mg administered twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy | The mean change in average daily pain score (ADPS) was measured using a 11-point numeric rating scale (NRS; 0 [no pain] to 10 [worst possible pain]. The rating averaged over a 7-day period and was based on entries in patients' daily pain diaries. Greater mean changes (improvements) in ADPS indicated better outcomes. A minimally meaningful effect was a mean decrease of at least 1.0 point [scale of 0 to 10] versus placebo. | Baseline to Week 7 postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Short Form-McGill Pain Questionnaire From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy | The Short Form-McGill Pain Questionnaire (SF-MPQ) Visual Analog Scale (VAS) is reported. For VAS, participants rated pain intensity on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain. Greater mean changes (improvements) in SF-MPQ indicated better outcomes. | at Week 7 postdose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Diabetic Peripheral Neuropathy