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ASP 8825 - Study in Patients With Painful Diabetic Polyneuropathy

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ClinicalTrials.gov Identifier: NCT00508430
Recruitment Status : Terminated (An independent DMC determined continuation was unlikely to demonstrate a statistically significant advantage of ASP8825 over placebo on the primary endpoint)
First Posted : July 30, 2007
Last Update Posted : December 5, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
To demonstrate the superiority of ASP8825 over placebo and dose response in patients with painful diabetic polyneuropathy.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathies Drug: ASP8825 Drug: Placebo Phase 2

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : July 2007
Primary Completion Date : November 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT00508430     History of Changes
Other Study ID Numbers: 8825-CL-0007
First Posted: July 30, 2007    Key Record Dates
Last Update Posted: December 5, 2008
Last Verified: December 2008

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