ASP 8825 - Study in Patients With Painful Diabetic Polyneuropathy

ASP 8825 Phase II Study-A Double- Blind, Placebo- Controlled Study in Patients With Painful Diabetic Polyneuropathy

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00508430

Enrollment

199

Registered

2007-07-30

Start date

2007-07-31

Completion date

2008-11-30

Last updated

2008-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathies

Keywords

ASP8825, Diabetic Neuropathies, Pain

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.

Interventions

DRUGASP8825

oral

DRUGPlacebo

oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 79 Years

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

Design outcomes

Primary

Measure	Time frame
Pain severity rating	8 week

Secondary

Measure	Time frame
Severity of numbness, maximum pain, night pain and sleep disturbance.	8 week
Responder rate	8 week
Patient's global impression of change	8 week
Clinical's global impression of change	8 week

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026