Dose-effect of SSR180575 in Diabetic Neuropathy | NCT00502515

Studies
Dose-effect of SSR180575 in Diabetic Neuropathy

NCT00502515

Sponsor

Sanofi

Status

Completed

Last Update Posted

Aug 8, 2017Actual

Enrollment

309Actual

Phase

Phase 2

Conditions

Diabetic Neuropathies

Interventions

SSR180575
Placebo

Countries

United States

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

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Feb 2009Actual

Completion Date

Feb 2009Actual

First Submitted Date

Jul 16, 2007

First Submission Date that Met QC Criteria

Jul 16, 2007

First Posted Date

Jul 17, 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

Aug 4, 2017

Certification/Extension First Submitted that Passed QC Review

Aug 4, 2017

Certification/Extension First Posted Date

Aug 8, 2017Actual

Last Update Submitted Date

Aug 4, 2017

Last Update Posted Date

Aug 8, 2017Actual

Description Module

Brief Summary

The primary objective of this sudy is to assess the effect of two doses of SSR180575 on the rate of regeneration of epidermal nerve fibers following denervation of the epidermal layer with capsaicin in patients with diabetes mellitus and mild peripheral neuropathy. Secondary objectives are to explore the efficacy of SSR180575 on clinical assessment, nerve function measures and to assess the tolerability and safety of SSR180575. The treatment period is 6 months.

Detailed Description

Not provided

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

309Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
25 mg SSR180575	Experimental	orally once daily for 24 weeks	Drug: SSR180575
100 mg SSR180575	Experimental	orally once daily for 24 weeks	Drug: SSR180575
Placebo	Placebo Comparator	orally once daily for 24 weeks	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SSR180575	Drug	Oral, once daily dosing	100 mg SSR180575 25 mg SSR180575

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of epidermal nerve fiber regeneration		24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Efficacy: change between baseline and 24 weeks of peripheral neuropathy assessed with nerve conduction studies, clinical evaluation, Total Neuropathy Score		24 weeks
Safety: physical examination, clinical laboratories, adverse event reporting		24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with Diabetes Mellitus, type I or II, treated or untreated
Diabetic neuropathy treated or untreated

Exclusion Criteria:

Patients with unstable glycemic control
Patients who have been hospitalized for a diabetes complication in the 3 months prior to randomization
Patients with peripheral neuropathy attributable to any cause other than diabetes
Non-measurable sural nerve sensory response on nerve conduction studies
Amputation of any part of lower extremity
Patients with a history of myocardial infarction or known coronary artery disease
Grade III or IV heart failure on New York Heart Association criteria

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 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
ICD CSD	Sanofi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Administrative Office		Bridgewater	New Jersey	08807	United States

Condition Browse Module

MeSH Terms

ID	Term
D003929	Diabetic Neuropathies
D003920	Diabetes Mellitus

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

Intervention Browse Module

MeSH Terms

ID	Term
C456740	SSR180575

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided