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NCT00043797 Clinical Trial

Lidorestat (IDD 676) for the Treatment of Diabetic Neuropathy

Diabetic Polyneuropathy Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00043797
Other study ID # 676/US/2-01
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received August 13, 2002
Last updated June 23, 2005

Study information
Verified date December 2002
Source The Institute for Diabetes Discovery, LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lidorestat (IDD 676)

Locations
Country Name City State
Canada Centre de Recherche Laval Quebec
Canada Hospital de L'Enfant-Jesus Quebec City Quebec
Canada Toronto General Hospital, University Health Network Toronto Ontario
United States Johns Hopkins University - School of Medicine Baltimore Maryland
United States University of Texas, Southwest Medical Center Dallas Texas
United States Radiant Research Gainesville Florida
United States Glendale Adventist Medical Center Glendale California
United States Marin Endocrinology Associates Greenbrae California
United States Brody School of Medicine, East Carolina University Greenville North Carolina
United States Diabetes & Endocrine Associates La Jolla California
United States University of Miami, Dept. of Diabetes, Endocrinology & Metabolism Miami Florida
United States University of Oklahoma Oklahoma City Oklahoma
United States Diabetes & Glandular Disease Clinic San Antonio Texas
United States Scottsdale Medical Specialists Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
The Institute for Diabetes Discovery, LLC

Countries where clinical trial is conducted

United States,  Canada, 

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