Back to resultsASP 8825 - Study in Patients With Painful Diabetic Polyneuropathy
Primary Purpose
Diabetic Neuropathies
Status
Terminated
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
ASP8825
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathies focused on measuring ASP8825, Diabetic Neuropathies, Pain
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
4
Arm Description
Low dose group
Middle dose group
High dose group
Outcomes
Primary Outcome Measures
Pain severity rating
Secondary Outcome Measures
Severity of numbness, maximum pain, night pain and sleep disturbance.
Responder rate
Patient's global impression of change
Clinical's global impression of change
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00508430
Brief Title
ASP 8825 - Study in Patients With Painful Diabetic Polyneuropathy
Official Title
ASP 8825 Phase II Study-A Double- Blind, Placebo- Controlled Study in Patients With Painful Diabetic Polyneuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Terminated
Why Stopped
An independent DMC determined continuation was unlikely to demonstrate a statistically significant advantage of ASP8825 over placebo on the primary endpoint
Study Start Date
July 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies
Keywords
ASP8825, Diabetic Neuropathies, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
199 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Low dose group
Arm Title
2
Arm Type
Experimental
Arm Description
Middle dose group
Arm Title
3
Arm Type
Experimental
Arm Description
High dose group
Arm Title
4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ASP8825
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral
Primary Outcome Measure Information:
Title
Pain severity rating
Time Frame
8 week
Secondary Outcome Measure Information:
Title
Severity of numbness, maximum pain, night pain and sleep disturbance.
Time Frame
8 week
Title
Responder rate
Time Frame
8 week
Title
Patient's global impression of change
Time Frame
8 week
Title
Clinical's global impression of change
Time Frame
8 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Chubu
Country
Japan
City
Chugoku
Country
Japan
City
Hokkaido
Country
Japan
City
Kansai
Country
Japan
City
Kanto
Country
Japan
City
Kyusyu
Country
Japan
City
Shikoku
Country
Japan
City
Touhoku
Country
Japan
12. IPD Sharing Statement
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ASP 8825 - Study in Patients With Painful Diabetic Polyneuropathy
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