Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes
NCT ID: NCT00044395
Last Updated: 2007-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
200 participants
INTERVENTIONAL
2002-07-31
2005-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Ruboxistaurin mesylate
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
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Irvine, California, United States
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Los Angeles, California, United States
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Tustin, California, United States
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New Britain, Connecticut, United States
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Weston, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Omaha, Nebraska, United States
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Henderson, Nevada, United States
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Medford, New Jersey, United States
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Buffalo, New York, United States
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Syracuse, New York, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Burlington, Vermont, United States
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Norfolk, Virginia, United States
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Morgantown, West Virginia, United States
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Camperdown, New South Wales, Australia
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Randwick, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Caulfield, Victoria, Australia
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Clayton, Victoria, Australia
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Edegem, , Belgium
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Huy, , Belgium
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Willebroek, , Belgium
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Aarhus C, , Denmark
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Keila, , Estonia
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Tallinn, , Estonia
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Dresden, , Germany
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Düsseldorf, , Germany
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Mainz, , Germany
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Budapest, , Hungary
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Debrecen, , Hungary
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Jerusalem, , Israel
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Santiago, La Coruna, Spain
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Madrid, Madrid, Spain
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Dos Hermanas, Sevilla, Spain
Countries
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Other Identifiers
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B7A-MC-MBBP
Identifier Type: -
Identifier Source: secondary_id
2133
Identifier Type: -
Identifier Source: org_study_id