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Lidorestat (IDD 676) for the Treatment of Diabetic Neuropathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2002 by The Institute for Diabetes Discovery, LLC.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
The Institute for Diabetes Discovery, LLC
ClinicalTrials.gov Identifier:
NCT00043797
First received: August 13, 2002
Last updated: June 23, 2005
Last verified: December 2002

August 13, 2002
June 23, 2005
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Complete list of historical versions of study NCT00043797 on ClinicalTrials.gov Archive Site
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Lidorestat (IDD 676) for the Treatment of Diabetic Neuropathy
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This clinical trial is to determine an effective dosage and to study the safety of an investigational drug -lidorestat (IDD-676)- which is intended to stop or slow the progression of diabetic peripheral neuropathy.

Diabetic peripheral neuropathy is one of the most important and serious complications of diabetes. It can cause pain and loss of sensation, loss of mobility and lead to chronic wounds and amputations. Studies indicate 50% or more of people who have diabetes now have or will have significant neuropathy.

Several currently marketed or investigational drugs are available to treat the painful symptoms of diabetic peripheral neuropathy, but there are no approved drugs that have been shown to prevent or slow the progression of the neuropathy itself.

The current clinical trial is an early phase II study designed to investigate the safety of the investigational drug lidorestat (IDD-676) and to determine the effect of various dose levels on important biochemical processes in the pathology of diabetic neuropathy.

Participants who enter and complete this study will, if the agent is successful, help in a very important way to bring an effective treatment from research laboratories to widespread availability for treatment. On the basis of the results of this study, large scale studies will be undertaken to support application for product registration and distribution in the U.S. and other countries throughout the world.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetic Polyneuropathy
Drug: Lidorestat (IDD 676)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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Inclusion:

  • Clinical diagnosis of Type 1 or Type II diabetes with mild to moderate diabetic peripheral neuropathy.
  • Healthy status except for diabetes
  • Ability to make frequent clinic visits over a 7-month period.
  • Willingness and ability to understand and sign consent form.

Exclusion:

  • Pregnancy or breast feeding
  • Presence of uncontrolled hypertension
  • History or presence of significant kidney or liver disease.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00043797
676/US/2-01
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The Institute for Diabetes Discovery, LLC
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The Institute for Diabetes Discovery, LLC
December 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP