NCT00508430

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

December 5, 2008

Status Verified

December 1, 2008

Enrollment Period

1.3 years

First QC Date

July 26, 2007

Last Update Submit

December 4, 2008

Conditions

Diabetic Neuropathies

Keywords

ASP8825Diabetic NeuropathiesPain

Outcome Measures

Primary Outcomes (1)

  • Pain severity rating

    8 week

Secondary Outcomes (4)

  • Severity of numbness, maximum pain, night pain and sleep disturbance.

    8 week

  • Responder rate

    8 week

  • Patient's global impression of change

    8 week

  • Clinical's global impression of change

    8 week

Study Arms (4)

1

EXPERIMENTAL

Low dose group

Drug: ASP8825

2

EXPERIMENTAL

Middle dose group

Drug: ASP8825

3

EXPERIMENTAL

High dose group

Drug: ASP8825

4

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ASP8825DRUG

oral

123
PlaceboDRUG

oral

4

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Chugoku, Japan

Location

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kanto, Japan

Location

Unknown Facility

Kyusyu, Japan

Location

Unknown Facility

Shikoku, Japan

Location

Unknown Facility

Tōhoku, Japan

Location

MeSH Terms

Conditions

Diabetic NeuropathiesPain

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 26, 2007

First Posted

July 30, 2007

Study Start

July 1, 2007

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

December 5, 2008

Record last verified: 2008-12

Locations

JP(8)