ASP 8825 - Study in Patients With Painful Diabetic Polyneuropathy

December 4, 2008 updated by: Astellas Pharma Inc

ASP 8825 Phase II Study-A Double- Blind, Placebo- Controlled Study in Patients With Painful Diabetic Polyneuropathy

To demonstrate the superiority of ASP8825 over placebo and dose response in patients with painful diabetic polyneuropathy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

199

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chubu, Japan
      • Chugoku, Japan
      • Hokkaido, Japan
      • Kansai, Japan
      • Kanto, Japan
      • Kyusyu, Japan
      • Shikoku, Japan
      • Touhoku, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 4
Drug: Placebo
oral
Experimental: 1
Low dose group
Drug: ASP8825
oral
Experimental: 2
Middle dose group
Drug: ASP8825
oral
Experimental: 3
High dose group
Drug: ASP8825
oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain severity rating
Time Frame: 8 week
8 week

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

July 26, 2007

First Submitted That Met QC Criteria

July 26, 2007

First Posted (Estimate)

July 30, 2007

Study Record Updates

Last Update Posted (Estimate)

December 5, 2008

Last Update Submitted That Met QC Criteria

December 4, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8825-CL-0007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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