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Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes
This study has been completed.
First Received: August 28, 2002   Last Updated: November 5, 2007   History of Changes
Sponsor: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00044395
  Purpose

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


Condition Intervention Phase
Diabetic Neuropathies
Diabetes Mellitus, Insulin-Dependent
Diabetes Mellitus, Non-Insulin-Dependent
 Drug: Ruboxistaurin mesylate
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: LY333531 Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1 Diabetic Nerve Problems Peripheral Nerve Disorders
Drug Information available for: Ruboxistaurin
U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Reduction in neuropathic symptoms

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 200
Study Start Date: July 2002
Study Completion Date: October 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00044395

  Hide Study Locations
Locations
United States, Arizona
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
Mesa, Arizona, United States
United States, California
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Los Angeles, California, United States
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Tustin, California, United States
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Irvine, California, United States
United States, Connecticut
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New Britain, Connecticut, United States
United States, Florida
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Weston, Florida, United States
United States, Georgia
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Atlanta, Georgia, United States
United States, Illinois
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Chicago, Illinois, United States
United States, Indiana
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Indianapolis, Indiana, United States
United States, Nebraska
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Omaha, Nebraska, United States
United States, Nevada
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Henderson, Nevada, United States
United States, New Jersey
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Medford, New Jersey, United States
United States, New York
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Buffalo, New York, United States
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Syracuse, New York, United States
United States, Texas
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Houston, Texas, United States
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Dallas, Texas, United States
United States, Vermont
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Burlington, Vermont, United States
United States, Virginia
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Norfolk, Virginia, United States
United States, West Virginia
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Morgantown, West Virginia, United States
Australia, New South Wales
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Randwick, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Camperdown, New South Wales, Australia
Australia, Victoria
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Caulfield, Victoria, Australia
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Clayton, Victoria, Australia
Belgium
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Huy, Belgium
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Edegem, Belgium
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Willebroeck, Belgium
Denmark
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Aarhus C, Denmark
Estonia
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Keila, Estonia
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Tallinn, Estonia
Germany
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Dusseldorf, Germany
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Dresden, Germany
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Mainz, Germany
Hungary
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Budapest, Hungary
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Debrecen, Hungary
Israel
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Jerusalem, Israel
Spain
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Madrid, Spain
Spain, La Coruna
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Santiago, La Coruna, Spain
Spain, Sevilla
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Dos Hermanas, Sevilla, Spain
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: 2133, B7A-MC-MBBP
Study First Received: August 28, 2002
Last Updated: November 5, 2007
ClinicalTrials.gov Identifier: NCT00044395     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Metabolic Diseases
Autoimmune Diseases
Molecular Mechanisms of Pharmacological Action
Diabetic Neuropathies
Immune System Diseases
Nervous System Diseases
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors
 Pharmacologic Actions
Diabetes Mellitus, Type 1
Neuromuscular Diseases
Ruboxistaurin
Peripheral Nervous System Diseases
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Diabetes Complications

ClinicalTrials.gov processed this record on November 27, 2009



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