ASP 8825 - Study in Patients With Painful Diabetic Polyneuropathy

Astellas

Status and phase: Terminated; Phase 2

Conditions: Diabetic Neuropathies

Treatments: Drug: ASP8825; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00508430

8825-CL-0007

Details and patient eligibility

About

To demonstrate the superiority of ASP8825 over placebo and dose response in patients with painful diabetic polyneuropathy.

Full description

Three doses of ASP8825 are compared to placebo in efficacy and safety point of view in patients with painful diabetic polyneuropathy.

Enrollment: 199 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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199 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

Low dose group

Treatment:

Drug: ASP8825

2

Experimental group

Description:

Middle dose group

Treatment:

Drug: ASP8825

3

Experimental group

Description:

High dose group

Treatment:

Drug: ASP8825

4

Placebo Comparator group

Treatment:

Drug: Placebo