Assessment of Efficacy and Safety of Thioctic Acid in the Oral Treatment of Symptomatic Diabetic Neuropathy (SYDNEY 2)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
|Study Start Date:||February 2005|
|Estimated Study Completion Date:||June 2005|
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.
|Wolfson Medical Center, Diabetes Unit|
|Holon, Israel, 58100|
|Haddassah Medical Center Ein Kerem, Diabetes Unit|
|Jerusalem, Israel, 91120|
|Chair of Endocrinology and Diabetology of Russian Medical Academy of Postgraduate Education at Central Clinical Hospital of Ministry of Communication RF|
|Moscow, Russian Federation, 125315|
|Chair of Nervous Diseases of IM Sechenov Moscow Medical Academy at City Clinical Hospital|
|Moscow, Russian Federation, 119048|
|Federal Centre of Medical Social Expertise and Rehabilitation of Invalids, Centre Diabetic Food|
|Moscow, Russian Federation, 127486|
|Principal Investigator:||Dan Ziegler, Prof.||German Diabetes Research Institute, Heinrich Heine University, Auf'm Hennekamp 65, D-40225 Düsseldorf, Germany|