Lidorestat (IDD 676) for the Treatment of Diabetic Neuropathy
NCT ID: NCT00043797
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
INTERVENTIONAL
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lidorestat (IDD 676)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Institute for Diabetes Discovery, LLC
INDUSTRY
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Scottsdale Medical Specialists
Scottsdale, Arizona, United States
Glendale Adventist Medical Center
Glendale, California, United States
Marin Endocrinology Associates
Greenbrae, California, United States
Diabetes & Endocrine Associates
La Jolla, California, United States
Radiant Research
Gainesville, Florida, United States
University of Miami, Dept. of Diabetes, Endocrinology & Metabolism
Miami, Florida, United States
Johns Hopkins University - School of Medicine
Baltimore, Maryland, United States
Brody School of Medicine, East Carolina University
Greenville, North Carolina, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
University of Texas, Southwest Medical Center
Dallas, Texas, United States
Diabetes & Glandular Disease Clinic
San Antonio, Texas, United States
Toronto General Hospital, University Health Network
Toronto, Ontario, Canada
Centre de Recherche
Laval, Quebec, Canada
Hospital de L'Enfant-Jesus
Québec, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Click here for more information on diabetes and diabetic neuropathy
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
676/US/2-01
Identifier Type: -
Identifier Source: org_study_id