ASP 8825 - Study in Patients With Painful Diabetic Polyneuropathy
Phase 2
Terminated
- Conditions
- Diabetic Neuropathies
- Interventions
- Drug: ASP8825Drug: Placebo
- Registration Number
- NCT00508430
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
To demonstrate the superiority of ASP8825 over placebo and dose response in patients with painful diabetic polyneuropathy.
- Detailed Description
Three doses of ASP8825 are compared to placebo in efficacy and safety point of view in patients with painful diabetic polyneuropathy.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 199
Inclusion Criteria
- Subjects aged 20 - 79 years
- Diabetes mellitus patients with diabetic polyneuropathy who have pain symptom for 26 weeks prior to the study
- Subjects who are compliant with diary completion
Exclusion Criteria
- Subjects who have pain from other diseases at the evaluating site
- Subjects who have nerve diseases at the evaluating site
- Subjects with foot ulcer or gangrene
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 ASP8825 Low dose group 2 ASP8825 Middle dose group 3 ASP8825 High dose group 4 Placebo -
- Primary Outcome Measures
Name Time Method Pain severity rating 8 week
- Secondary Outcome Measures
Name Time Method Responder rate 8 week Severity of numbness, maximum pain, night pain and sleep disturbance. 8 week Patient's global impression of change 8 week Clinical's global impression of change 8 week