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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: NCT00044408
  Purpose

The purpose of this protocol is to determine if an investigational drug known as LY333531 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 of 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 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: NCT00044408

  Hide Study Locations
Locations
United States, California
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Long Beach, California, United States
United States, Connecticut
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Norwalk, Connecticut, United States
United States, Florida
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Plantation, Florida, United States
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Clearwater, Florida, United States
United States, Idaho
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Idaho Falls, Idaho, United States
United States, Illinois
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North Chicago, Illinois, United States
United States, Maryland
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Baltimore, Maryland, United States
United States, Massachusetts
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Boston, Massachusetts, United States
United States, Minnesota
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Minneapolis, Minnesota, United States
United States, Missouri
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Columbia, Missouri, United States
United States, New York
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New York, New York, United States
United States, South Carolina
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Columbia, South Carolina, United States
United States, Texas
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San Antonio, Texas, United States
Canada, British Columbia
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Vancouver, British Columbia, Canada
Canada, Manitoba
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Winnipeg, Manitoba, Canada
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada
Canada, Ontario
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Toronto, Ontario, Canada
Canada, Prince Edward Island
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Charlottetown, Prince Edward Island, Canada
Canada, Quebec
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Laval, Quebec, Canada
Croatia
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Zagreb, Croatia
Finland
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Jyvaskyla, Finland
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Oulu, Finland
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Helsinki, Finland
India
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Hyderabad, India
India, Chennai
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Gopalapuram, Chennai, India
India, Maharashtra
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Mumbai, Maharashtra, India
Lithuania
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Vilnus, Lithuania
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Klaipeda, Lithuania
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Kaunas, Lithuania
Netherlands
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Amersfoort, Netherlands
United Kingdom
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Manchester, United Kingdom
United Kingdom, Dorset
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Poole, Dorset, United Kingdom
United Kingdom, Manchester
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Salford, Manchester, United Kingdom
United Kingdom, Shropshire
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Shrewsbury, Shropshire, United Kingdom
United Kingdom, South Yorkshire
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Sheffield, South Yorkshire, United Kingdom
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 - 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: 6204, B7A-MC-MBCW
Study First Received: August 28, 2002
Last Updated: November 5, 2007
ClinicalTrials.gov Identifier: NCT00044408     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 30, 2009



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