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Assessment of Efficacy and Safety of Thioctic Acid in the Oral Treatment of Diabetic Polyneuropathy (Stage 1 or 2) — NATHAN1  

Diabetic Polyneuropathy Clinical Trial

Official title:
Assessment of Efficacy and Safety of Thioctic Acid in the Oral Treatment of Diabetic Polyneuropathy (Stage 1 or 2) NATHAN1 A Randomized, Placebo-controlled, Double-blind Multi-centre Trial With 2 Parallel Groups

Clinical Trial Summary

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

Clinical Trial Description

Stage 1 or 2a diabetic (poly)neuropathy (DNP) (Appendix 3) in patients with diabetes mellitus (type I or II); neuropathy impairment score of the lower limbs, enlarged by 7 objective items (NISLL+7) ≥ 97.5 percentile (corresponding to 4.43 score points); total symptoms score of the feet (TSSfeet) ≤ 5. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00977483
Study type Interventional
Source Viatris Inc.
Contact
Status Completed
Phase Phase 3
Start date May 1998
Completion date January 2005
View Details
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