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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014