Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043797
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2002-08-13
Brief Title:
Lidorestat IDD 676 for the Treatment of Diabetic Neuropathy
Sponsor:
The Institute for Diabetes Discovery LLC
Organization:
The Institute for Diabetes Discovery LLC
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2002-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 US and other countries throughout the world
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 US and other countries throughout the world
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None