Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes

November 5, 2007 updated by: Eli Lilly and Company

LY333531 Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes

The purpose of this protocol is to determine if an investigational drug is effective in treating nerve malfunction in diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: Ruboxistaurin mesylate

Study Type

Interventional

Enrollment

200

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- New South Wales
  - Camperdown, New South Wales, Australia
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  - Randwick, New South Wales, Australia
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  - St Leonards, New South Wales, Australia
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
- Victoria
  - Caulfield, Victoria, Australia
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  - Clayton, Victoria, Australia
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Belgium
- - Edegem, Belgium
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  - Huy, Belgium
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  - Willebroeck, Belgium
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Denmark
- - Aarhus C, Denmark
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Estonia
- - Keila, Estonia
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  - Tallinn, Estonia
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Germany
- - Dresden, Germany
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  - Dusseldorf, Germany
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  - Mainz, Germany
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Hungary
- - Budapest, Hungary
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  - Debrecen, Hungary
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Israel
- - Jerusalem, Israel
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Spain
- - Madrid, Spain
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
- La Coruna
  - Santiago, La Coruna, Spain
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
- Sevilla
  - Dos Hermanas, Sevilla, Spain
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
United States
- Arizona
  - Mesa, Arizona, United States
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
- California
  - Irvine, California, United States
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  - Los Angeles, California, United States
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  - Tustin, California, United States
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
- Connecticut
  - New Britain, Connecticut, United States
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
- Florida
  - Weston, Florida, United States
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
- Georgia
  - Atlanta, Georgia, United States
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
- Illinois
  - Chicago, Illinois, United States
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
- Indiana
  - Indianapolis, Indiana, United States
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
- Nebraska
  - Omaha, Nebraska, United States
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
- Nevada
  - Henderson, Nevada, United States
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
- New Jersey
  - Medford, New Jersey, United States
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
- New York
  - Buffalo, New York, United States
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  - Syracuse, New York, United States
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
- Texas
  - Dallas, Texas, United States
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  - Houston, Texas, United States
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
- Vermont
  - Burlington, Vermont, United States
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
- Virginia
  - Norfolk, Virginia, United States
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
- West Virginia
  - Morgantown, West Virginia, United States
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients must have type I or type II Diabetes Mellitus.
Have clinically diagnosed positive sensory symptoms such as numbness, lancinating pain, burning pain, aching pain, allodynia and prickling sensation that have been present not greater than 5 years but stable for 6 months.
Has a HbA1C less than or equal to 12%. Patients with HbA1C greater than 9% must be on insulin therapy.
Must be 18 years or older.
Be able to visit the doctor's office approximately 3 times over a maximum of a 6-week period to determine if you can continue in the study.

Exclusion Criteria:

History of significant liver problems.
Have poor kidney function.
Drink an excess of alcohol or abuse drugs.
Have recently participated or currently participating in a Medical study in which you receive an experimental drug.
Are a woman and are pregnant or breastfeeding, intend to become pregnant within the next 2 years or a woman not using effective birth control.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reduction in neuropathic symptoms

Secondary Outcome Measures

Outcome Measure
Vibration sensation;Neurological signs;Electrophysiology of peroneal, tibial and sural nerves;Relief of symptoms as measured by VAS;Composite scores of nerve function;Clinical global impression of change

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

August 28, 2002

First Submitted That Met QC Criteria

August 29, 2002

First Posted (Estimate)

August 30, 2002

Study Record Updates

Last Update Posted (Estimate)

November 6, 2007

Last Update Submitted That Met QC Criteria

November 5, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

2133 (Other Grant/Funding Number: European Union Funding for Research and Innovation - HORIZON 2020)
B7A-MC-MBBP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Neuropathies

AstraZeneca

Completed

Safety, Tolerability and Preliminary Efficacy of AZD5213 in Combination With Pregabalin in Subjects With PDN and Good Pain Reporting Ability

Diabetic Neuropathy, Painful; Diabetic Neuropathies

United States
Maastricht University Medical Center

Completed

Graded Exposure in Patients With Painful Diabetic Neuropathy (PDN&GEXP)

Painful Diabetic Neuropathy | Diabetic Neuropathies, Painful | Neuralgia, Diabetic

Netherlands
WinSanTor, Inc

Completed

A 24-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Peripheral Neuropathy

Peripheral Neuropathy | Painful Diabetic Neuropathy | Diabetic Neuropathies, Painful

Canada
Helixmith Co., Ltd.

Completed

Safety and Efficacy Study for the Treatment of Painful Diabetic Neuropathy

Painful Diabetic Neuropathies

United States, Korea, Republic of
Imperial College London
Actegy Ltd.

Not yet recruiting

Neuromuscular Electrical Stimulation For The Treatment of Diabetic Neuropathy (NMES-DN)

Diabetic Neuropathies | Diabetic Peripheral Neuropathy | Diabetic Polyneuropathy | Diabetic Complication

United Kingdom
Corporacion Parc Tauli

Completed

The Efficacy and Safety Profile of Capsaicin 8% Patch Versus 5% Lidocaine Patch in Males With Diabetic Neuropathy

Diabetic Neuropathy | Diabetic Nerve Problems | Diabetic Complications Neurological

Pakistan
University Medical Centre Ljubljana

Unknown

Transcutaneous Application of Gaseous CO2

Peripheral Diabetic Neuropathy

Slovenia
Timothy J. Best Medicine Professional Corporation
The Physicians' Services Incorporated Foundation

Completed

Surgical Decompression for Diabetic Neuropathy in the Foot

Diabetic Polyneuropathy

Canada
AbbVie (prior sponsor, Abbott)

Completed

Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

Diabetic Neuropathies | Diabetic Neuropathy, Painful | Diabetic Polyneuropathy | Diabetic Neuralgia | Neuralgia, Diabetic

United States, Canada, France, Germany, Italy, Mexico, Puerto Rico
Eva Pharma
MARC-CRO

Recruiting

Phase IV Trial to Evaluate Efficacy of Alpha-Lipoic Acid in Treating Symptomatic Diabetic Polyneuropathy in Egypt (MIRACLE-ALA)

Polyneuropathy, Diabetic

Egypt

Clinical Trials on Ruboxistaurin mesylate

Chromaderm, Inc.

Completed

Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes

Diabetic Neuropathies | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Mellitus, Insulin-Dependent

Canada, United States, Croatia, Finland, India, Lithuania, Netherlands, United Kingdom
Eli Lilly and Company

Completed

Treatment of Peripheral Neuropathy in Patients With Diabetes

Diabetes Mellitus | Diabetic Neuropathies

United States, Spain, Australia, Belgium, Canada, Croatia, Denmark, Estonia, Finland, Germany, Hungary, India, Lithuania, Netherlands, United Kingdom
Chromaderm, Inc.
Heart and Stroke Foundation of Canada

Completed

Renal and Peripheral Hemodynamic Function in Patients With Type 1 Diabetes Mellitus

Diabetes Mellitus, Type 1

Canada
Chromaderm, Inc.

Completed

Protein Kinase C (PKC) Inhibitor-Diabetic Retinopathy Phase 3 Study

Diabetic Retinopathy

United States
Chromaderm, Inc.

Completed

Reduction in the Occurrence of Center-Involved Diabetic Macular Edema

Diabetic Retinopathy

United States, Canada, France, Denmark, Australia, Netherlands, Taiwan, Spain, Italy, Germany, Portugal, United Kingdom, Russian Federation, Poland, India, Brazil, Mexico
Chromaderm, Inc.

Completed

Isoprostane/FMD Study The Effect of Protein Kinase C (PKC) β Specific Inhibitor LY333531 on Oxidant Stress in Patients With Type 2 Diabetes Mellitus

Diabetes Mellitus

United States
Chromaderm, Inc.

Completed

The Effect of LY333531 on Protein in the Urine in Patients With Type 2 Diabetes

Diabetic Nephropathy

United States
University of Tennessee
The Christ Hospital

Withdrawn

Ruboxistaurin in New York Heart Failure Classification III-IV Patients

Heart Failure

United States
Chromaderm, Inc.

Completed

Effect of Ruboxistaurin on Clinically Significant Macular Edema

Diabetic Macular Edema

United States, Denmark, Mexico, Germany, Spain, Canada, Lithuania, Portugal, Romania, United Kingdom
Chromaderm, Inc.

Completed

The Effect of Ruboxistaurin on Small Fiber Function

Diabetic Neuropathy

United States

Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes

LY333531 Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Secondary Outcome Measures

Outcome Measure

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Diabetic Neuropathies

Clinical Trials on Ruboxistaurin mesylate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations