ASP 8825 - Study in Patients With Painful Diabetic Polyneuropathy

Diabetic Neuropathies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00508430
• Other study ID #: 8825-CL-0007
• Status: Terminated
• Phase: Phase 2
• First received: July 26, 2007
• Last updated: December 4, 2008
• Start date: July 2007
• Est. completion date: November 2008

Study information

• Verified date: December 2008
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 199
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Polyneuropathies

Intervention

Drug:
• ASP8825
oral
• Placebo
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain severity rating		8 week	Yes
Secondary	Severity of numbness, maximum pain, night pain and sleep disturbance.		8 week	No
Secondary	Responder rate		8 week	No
Secondary	Patient's global impression of change		8 week	No
Secondary	Clinical's global impression of change		8 week	No