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Effects of Benfotiamine on Intraepidermal Nerve Fiber Density (IENFD)

NCT01868191 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2013-06-04

No results posted yet for this study

Summary

The aim of the present study is to assess before, as well as 6 and 12 months following a therapy with benfotiamine the influence of therapy on intraepidermal nerve fiber density (skin biopsy) and neuropathic symptoms and deficits in people with type 1 or 2 diabetes mellitus and diabetic sensomotoric neuropathy.

Conditions

  • Diabetic Neuropathies

Interventions

DRUG

Benfotiamine

Treatment with 600 mg/day for the first 3 months followed by 300 mg/day for 9 months

DRUG

Placebo for benfotiamine

Treatment with placebo for benfotiamine 600 mg/day for the first 3 months followed by 300 mg/day for 9 months

Sponsors & Collaborators

  • Woerwag Pharma GmbH & Co. KG

    collaborator INDUSTRY

  • Diabetes Schwerpunktpraxis

    lead OTHER

Principal Investigators

  • Alin O Stirban, MD, PhD · Diabetes Schwerpunktpraxis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Germany

Study Locations

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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 NCT01868191 on ClinicalTrials.gov