The purpose of this study is to assess analgesic efficacy of ASP3662 relative to placebo in subjects with painful diabetic peripheral neuropathy (PDPN) as well as assess the safety and tolerability of ASP3662 relative to placebo. The analgesic effect is evaluated by measuring percent responders, change in daily worst pain score, change in average daily pain score, Patient Global Impression of Change (PGIC) and Clinical Global Impression of Change (CGIC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
115
Change from Baseline in mean 24-hour average pain intensity as reported on the NPRS
Numerical Pain Rating Scale (NPRS)
Time frame: Baseline to Week 6/ End of Treatment (EOT)
Percentage of Responders in mean 24-hour average pain intensity score
Time frame: Baseline to Week 6/ EOT
Change from Baseline in mean of 24-hour average pain intensity score
Time frame: Baseline to Weeks 1, 2, 3, 4, 5 and 6
Change from Baseline in mean daily worst pain score
Time frame: Baseline to Week 6/ EOT
Change from Baseline in mean daily average pain score
Time frame: Baseline to Week 6/ EOT
Patient Global Impression Change (PGIC)
Time frame: Week 6/ EOT
Clinical Global Impression of Change (CGIC)
Time frame: Week 6/ EOT
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