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Sponsored by: |
The Institute for Diabetes Discovery, LLC |
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Information provided by: | The Institute for Diabetes Discovery, LLC |
ClinicalTrials.gov Identifier: | NCT00043797 |
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.
Condition | Intervention | Phase |
---|---|---|
Diabetic Polyneuropathy |
Drug: Lidorestat (IDD 676) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
United States, Arizona | |
Scottsdale Medical Specialists | |
Scottsdale, Arizona, United States | |
United States, California | |
Marin Endocrinology Associates | |
Greenbrae, California, United States | |
Diabetes & Endocrine Associates | |
La Jolla, California, United States, 92037 | |
Glendale Adventist Medical Center | |
Glendale, California, United States, 91206 | |
United States, Florida | |
University of Miami, Dept. of Diabetes, Endocrinology & Metabolism | |
Miami, Florida, United States, 33136 | |
Radiant Research | |
Gainesville, Florida, United States, 32605 | |
United States, Maryland | |
Johns Hopkins University - School of Medicine | |
Baltimore, Maryland, United States, 21205 | |
United States, North Carolina | |
Brody School of Medicine, East Carolina University | |
Greenville, North Carolina, United States | |
United States, Oklahoma | |
University of Oklahoma | |
Oklahoma City, Oklahoma, United States | |
United States, Texas | |
Diabetes & Glandular Disease Clinic | |
San Antonio, Texas, United States | |
University of Texas, Southwest Medical Center | |
Dallas, Texas, United States | |
Canada, Ontario | |
Toronto General Hospital, University Health Network | |
Toronto, Ontario, Canada | |
Canada, Quebec | |
Centre de Recherche | |
Laval, Quebec, Canada | |
Hospital de L'Enfant-Jesus | |
Quebec City, Quebec, Canada |
Study ID Numbers: | 676/US/2-01 |
Study First Received: | August 13, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00043797 |
Health Authority: | United States: Food and Drug Administration |
ARI Diabetic polyneuropathy Diabetic complications |
Neuromuscular Diseases Diabetic Neuropathies Peripheral Nervous System Diseases Diabetes Mellitus |
Polyneuropathies Endocrine System Diseases Endocrinopathy Diabetes Complications |
Nervous System Diseases |