CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed
Drug / intervention
Thioctic Aciddrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00328601
NCT00328601Phase 3Completed
CompareCT.gov

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

MEDA Pharma GmbH & Co. KG·interventional·Posted May 22, 2006·Updated Feb 7, 2022

In Brief

A Phase 3 clinical trial evaluating Thioctic Acid for Diabetic Polyneuropathy. Completed, across 5 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Polyneuropathy
CountriesIsrael, Russia
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 22, 2006
Enrollment StartFeb 1, 2005
Study CompletionJun 1, 2005
TodayJul 2, 2026
Posted 20.1 years ago

Interventions

Thioctic Aciddrug