NCT00043797

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
2 countries

14 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2002

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 2002

First QC Date

August 13, 2002

Last Update Submit

June 23, 2005

Conditions

Keywords

ARIDiabetic polyneuropathyDiabetic complications

Interventions

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnancy or breast feeding
  • Presence of uncontrolled hypertension
  • History or presence of significant kidney or liver disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Scottsdale Medical Specialists

Scottsdale, Arizona, United States

Location

Glendale Adventist Medical Center

Glendale, California, 91206, United States

Location

Marin Endocrinology Associates

Greenbrae, California, United States

Location

Diabetes & Endocrine Associates

La Jolla, California, 92037, United States

Location

Radiant Research

Gainesville, Florida, 32605, United States

Location

University of Miami, Dept. of Diabetes, Endocrinology & Metabolism

Miami, Florida, 33136, United States

Location

Johns Hopkins University - School of Medicine

Baltimore, Maryland, 21205, United States

Location

Brody School of Medicine, East Carolina University

Greenville, North Carolina, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, United States

Location

University of Texas, Southwest Medical Center

Dallas, Texas, United States

Location

Diabetes & Glandular Disease Clinic

San Antonio, Texas, United States

Location

Toronto General Hospital, University Health Network

Toronto, Ontario, Canada

Location

Centre de Recherche

Laval, Quebec, Canada

Location

Hospital de L'Enfant-Jesus

Québec, Quebec, Canada

Location

Related Links

MeSH Terms

Conditions

Diabetic NeuropathiesDiabetes Complications

Interventions

lidorestat

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes MellitusEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 13, 2002

First Posted

August 15, 2002

Last Updated

June 24, 2005

Record last verified: 2002-12

Locations