ASP 8825 - Study in Patients With Painful Diabetic Polyne... | NCT00508430

Studies
ASP 8825 - Study in Patients With Painful Diabetic Polyneuropathy

NCT00508430

Sponsor

Astellas Pharma Inc

Status

Terminated

Last Update Posted

Dec 5, 2008Estimated

Enrollment

199Actual

Phase

Phase 2

Conditions

Diabetic Neuropathies

Interventions

ASP8825
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

An independent DMC determined continuation was unlikely to demonstrate a statistically significant advantage of ASP8825 over placebo on the primary endpoint

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Nov 2008Actual

Completion Date

Nov 2008Actual

First Submitted Date

Jul 26, 2007

First Submission Date that Met QC Criteria

Jul 26, 2007

First Posted Date

Jul 30, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2008

Last Update Posted Date

Dec 5, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Astellas Pharma IncINDUSTRY

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

199Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ASP8825	Drug	oral	1 2 3
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain severity rating		8 week

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Central Contact	Astellas Pharma Inc	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Chugoku			Japan

Condition Browse Module

MeSH Terms

ID	Term
D003929	Diabetic Neuropathies
D010146	Pain

Ancestor Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D048909	Diabetes Complications

Browse Leaves

Not provided

Browse Branches

Not provided