ASP 8825 - Study in Patients With Painful Diabetic Polyneuropathy

Phase 2

Terminated

• Conditions: Diabetic Neuropathies
• Interventions: Drug: ASP8825; Drug: 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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-26
• Study First Submitted QC: 2007-07-26
• Study First Posted: 2007-07-30
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-04
• Last Update Posted: 2008-12-05

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