Lidorestat (IDD 676) for the Treatment of Diabetic Neuropathy
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ClinicalTrials.gov Identifier: NCT00043797 |
Recruitment Status
: Unknown
Verified December 2002 by The Institute for Diabetes Discovery, LLC.
Recruitment status was: Active, not recruiting
First Posted
: August 15, 2002
Last Update Posted
: June 24, 2005
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Tracking Information | |||
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First Submitted Date ICMJE | August 13, 2002 | ||
First Posted Date ICMJE | August 15, 2002 | ||
Last Update Posted Date | June 24, 2005 | ||
Study Start Date ICMJE | Not Provided | ||
Primary Completion Date | Not Provided | ||
Current Primary Outcome Measures ICMJE | Not Provided | ||
Original Primary Outcome Measures ICMJE | Not Provided | ||
Change History | No Changes Posted | ||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Lidorestat (IDD 676) for the Treatment of Diabetic Neuropathy | ||
Official Title ICMJE | Not Provided | ||
Brief 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. | ||
Detailed 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. |
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Study Type ICMJE | Interventional | ||
Study Phase | Phase 2 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment |
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Condition ICMJE | Diabetic Polyneuropathy | ||
Intervention ICMJE | Drug: Lidorestat (IDD 676) | ||
Study Arms | Not Provided | ||
Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Unknown status | ||
Enrollment ICMJE | Not Provided | ||
Original Enrollment ICMJE | Not Provided | ||
Study Completion Date | Not Provided | ||
Primary Completion Date | Not Provided | ||
Eligibility Criteria ICMJE | Inclusion:
Exclusion:
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Sex/Gender |
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Ages | 18 Years to 70 Years (Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Canada, United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00043797 | ||
Other Study ID Numbers ICMJE | 676/US/2-01 | ||
Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Not Provided | ||
Study Sponsor ICMJE | The Institute for Diabetes Discovery, LLC | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | The Institute for Diabetes Discovery, LLC | ||
Verification Date | December 2002 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |