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Assessment of Efficacy and Safety of Thioctic Acid in the Oral Treatment of Diabetic Polyneuropathy (Stage 1 or 2)

NCT00977483 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2022-02-07

No results posted yet for this study

Summary

To assess clinical efficacy and safety of long-term orally administered thioctic acid in the treatment of diabetic polyneuropathy.

Conditions

  • Diabetic Polyneuropathy

Interventions

DRUG

Thioctic Acid

600mg tablet once daily 4 years double-blind treatment period

DRUG

Placebo

1 tablet once daily 4 years double-blind treatment period

Sponsors & Collaborators

  • Clinquest, Inc.

    collaborator INDUSTRY

  • Ergomed

    collaborator INDUSTRY

  • Quintiles, Inc.

    collaborator INDUSTRY

  • MEDA Pharma GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Peter James Dyck · Mayo Clinic, Dept. of Neurology, 200 First Street Southwest, Rochester, MN 55905, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
1998-05-31
Primary Completion
2005-01-31
Completion
2005-01-31

Countries

  • United States
  • Croatia
  • Denmark
  • France
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT00977483 on ClinicalTrials.gov