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Dose-effect of SSR180575 in Diabetic Neuropathy

NCT00502515 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 309

Last updated 2017-08-08

No results posted yet for this study

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.

Conditions

  • Diabetic Neuropathies

Interventions

DRUG

SSR180575

Oral, once daily dosing

DRUG

Placebo

Oral, once daily dosing

Sponsors & Collaborators

Principal Investigators

  • ICD CSD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00502515 on ClinicalTrials.gov