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Sponsored by: |
MEDA Pharma GmbH & Co. KG |
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Information provided by: | MEDA Pharma GmbH & Co. KG |
ClinicalTrials.gov Identifier: | NCT00328601 |
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.
Condition | Intervention | Phase |
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Diabetic Polyneuropathy |
Drug: Thioctic Acid |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 170 |
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.
Ages Eligible for Study: | 18 Years to 74 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Lack of suitability for the trial:
Existing foot ulcers.
Safety concerns:
History of allergic reaction to the study medication or its excipients.
Administrative reasons:
Israel | |
Haddassah Medical Center Ein Kerem, Diabetes Unit | |
Jerusalem, Israel, 91120 | |
Wolfson Medical Center, Diabetes Unit | |
Holon, Israel, 58100 | |
Russian Federation | |
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 |
Study ID Numbers: | D-20557-3258 |
Study First Received: | May 19, 2006 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00328601 History of Changes |
Health Authority: | Russia: Ethics Committee; Israel: Ethics Commission |
Antioxidants Vitamin B Complex Diabetic Neuropathies Polyneuropathies Diabetes Mellitus Endocrine System Diseases Trace Elements |
Neuromuscular Diseases Peripheral Nervous System Diseases Vitamins Endocrinopathy Micronutrients Diabetes Complications Thioctic Acid |
Antioxidants Vitamin B Complex Molecular Mechanisms of Pharmacological Action Diabetic Neuropathies Growth Substances Physiological Effects of Drugs Nervous System Diseases Polyneuropathies Diabetes Mellitus |
Endocrine System Diseases Protective Agents Pharmacologic Actions Neuromuscular Diseases Peripheral Nervous System Diseases Vitamins Micronutrients Diabetes Complications Thioctic Acid |