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ASP 8825 - Study in Patients With Painful Diabetic Polyneuropathy

This study has been terminated.
(An independent DMC determined continuation was unlikely to demonstrate a statistically significant advantage of ASP8825 over placebo on the primary endpoint)
Information provided by:
Astellas Pharma Inc Identifier:
First received: July 26, 2007
Last updated: December 4, 2008
Last verified: December 2008
To demonstrate the superiority of ASP8825 over placebo and dose response in patients with painful diabetic polyneuropathy.

Condition Intervention Phase
Diabetic Neuropathies
Drug: ASP8825
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ASP 8825 Phase II Study—A Double- Blind, Placebo- Controlled Study in Patients With Painful Diabetic Polyneuropathy

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Pain severity rating [ Time Frame: 8 week ]

Secondary Outcome Measures:
  • Severity of numbness, maximum pain, night pain and sleep disturbance. [ Time Frame: 8 week ]
  • Responder rate [ Time Frame: 8 week ]
  • Patient's global impression of change [ Time Frame: 8 week ]
  • Clinical's global impression of change [ Time Frame: 8 week ]

Enrollment: 199
Study Start Date: July 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Low dose group
Drug: ASP8825
Experimental: 2
Middle dose group
Drug: ASP8825
Experimental: 3
High dose group
Drug: ASP8825
Placebo Comparator: 4 Drug: Placebo

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

Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00508430

Chubu, Japan
Chugoku, Japan
Hokkaido, Japan
Kansai, Japan
Kanto, Japan
Kyusyu, Japan
Shikoku, Japan
Touhoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Central Contact Astellas Pharma Inc
  More Information

Responsible Party: Director, Astellas Pharma, Inc Identifier: NCT00508430     History of Changes
Other Study ID Numbers: 8825-CL-0007
Study First Received: July 26, 2007
Last Updated: December 4, 2008

Keywords provided by Astellas Pharma Inc:
Diabetic Neuropathies

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases processed this record on April 28, 2017