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Assessment of Efficacy and Safety of Thioctic Acid in the Oral Treatment of Symptomatic Diabetic Neuropathy (SYDNEY 2)

Diabetic Polyneuropathy Clinical Trial

Official title:
Assessment of Efficacy and Safety of Thioctic Acid in the Oral Treatment of Symptomatic Diabetic Neuropathy (SYDNEY 2) Randomised, Double-blind,Placebo-controlled Multicentre Trial With 4 Parallel Groups

Clinical Trial Summary

The primary objective of the trial is to determine the optimal dose of orally (tablet) administered thioctic acid in the treatment of symptoms of diabetic polyneuropathy (dPNP). It is expected that at least one of the three dosages to be tested (600, 1200, or 1800 mg tablets) of orally administered thioctic acid improves the symptoms of dPNP as compared to placebo. Secondary objectives are evaluations of other variables pertinent to dPNP, safety, and tolerability.

Clinical Trial Description

Following a screening visit, patients will receive placebo oral for 7 days. Eligible patients with chronic symptoms will then randomly be assigned to one of 4 treatment groups and treated with trial medication for 5 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00328601
Study type Interventional
Source Viatris Inc.
Contact
Status Completed
Phase Phase 3
Start date February 2005
Completion date June 2005
View Details
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