drugset

drugset / Trial / NCT00977483

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

NCT00977483 ↗

Phase 3 Completed 460 enrolled MEDA Pharma GmbH & Co. KG Clinquest, Inc. · collab Ergomed GmbH · collab Quintiles, Inc. · collab

RandomizedSingle-groupQuadruple-blindTreatment

Summary

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

Timeline

Start: 1998-05
Primary completion: 2005-01
Completion: 2005-01

Publications

Ziegler D, Low PA, Litchy WJ, Boulton AJ, Vinik AI, Freeman R, Samigullin R, Tritschler H, Munzel U, Maus J, Schutte K, Dyck PJ. Efficacy and safety of antioxidant treatment with alpha-lipoic acid over 4 years in diabetic polyneuropathy: the NATHAN 1 trial. Diabetes Care. 2011 Sep;34(9):2054-60. doi: 10.2337/dc11-0503. Epub 2011 Jul 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Thioctic Acid	Unknown	600 mg	Oral

Indications