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ASP 8825 - Study in Patients With Painful Diabetic Polyneuropathy

NCT ID: NCT00508430

Last Updated: 2008-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-11-30

Brief Summary

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

Detailed Description

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

Conditions

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Diabetic Neuropathies

Keywords

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ASP8825 Diabetic Neuropathies Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Low dose group

Group Type EXPERIMENTAL

ASP8825

Intervention Type DRUG

oral

2

Middle dose group

Group Type EXPERIMENTAL

ASP8825

Intervention Type DRUG

oral

3

High dose group

Group Type EXPERIMENTAL

ASP8825

Intervention Type DRUG

oral

4

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral

Interventions

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ASP8825

oral

Intervention Type DRUG

Placebo

oral

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Astellas Pharma, Inc

Principal Investigators

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Central Contact

Role: STUDY_CHAIR

Astellas Pharma Inc

Locations

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Chugoku, , Japan

Site Status

Chūbu, , Japan

Site Status

Hokkaido, , Japan

Site Status

Kansai, , Japan

Site Status

Kanto, , Japan

Site Status

Kyusyu, , Japan

Site Status

Shikoku, , Japan

Site Status

Tōhoku, , Japan

Site Status

Countries

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Japan

Other Identifiers

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8825-CL-0007

Identifier Type: -

Identifier Source: org_study_id