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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
450
Unnamed facility
Tokyo, Japan
Unnamed facility
Seoul, South Korea
Unnamed facility
Taipei, Taiwan
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.
Time frame: Baseline to Week 7 postdose
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.
Time frame: at Week 7 postdose
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DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day
Pregabalin oral capsules 150 mg administered twice a day