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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)
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00508430
First received: July 26, 2007
Last updated: December 4, 2008
Last verified: December 2008
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Pain severity rating [ Time Frame: 8 week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Severity of numbness, maximum pain, night pain and sleep disturbance. [ Time Frame: 8 week ] [ Designated as safety issue: No ]
  • Responder rate [ Time Frame: 8 week ] [ Designated as safety issue: No ]
  • Patient's global impression of change [ Time Frame: 8 week ] [ Designated as safety issue: No ]
  • Clinical's global impression of change [ Time Frame: 8 week ] [ Designated as safety issue: No ]

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
oral
Experimental: 2
Middle dose group
 Drug: ASP8825
oral
Experimental: 3
High dose group
 Drug: ASP8825
oral
Placebo Comparator: 4 Drug: Placebo
oral

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00508430

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

No publications provided

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT00508430     History of Changes
Other Study ID Numbers: 8825-CL-0007
Study First Received: July 26, 2007
Last Updated: December 4, 2008
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
ASP8825
Diabetic Neuropathies
Pain

Additional relevant MeSH terms:
Diabetic Neuropathies
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013