To demonstrate the superiority of ASP8825 over placebo and dose response in patients with painful diabetic polyneuropathy.
Three doses of ASP8825 are compared to placebo in efficacy and safety point of view in patients with painful diabetic polyneuropathy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
199
Unnamed facility
Chugoku, Japan
Unnamed facility
Chūbu, Japan
Unnamed facility
Hokkaido, Japan
Unnamed facility
Kansai, Japan
Unnamed facility
Kanto, Japan
Pain severity rating
Time frame: 8 week
Severity of numbness, maximum pain, night pain and sleep disturbance.
Time frame: 8 week
Responder rate
Time frame: 8 week
Patient's global impression of change
Time frame: 8 week
Clinical's global impression of change
Time frame: 8 week
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Kyusyu, Japan
Unnamed facility
Shikoku, Japan
Unnamed facility
Tōhoku, Japan