Treatment of Peripheral Neuropathy in Patients With Diabetes
NCT ID: NCT00044421
Last Updated: 2007-11-06
Study Results
Results pending
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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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
400 participants
Study Classification
INTERVENTIONAL
Study Start Date
2002-07-31
Study Completion Date
2006-10-31
Brief Summary
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The purpose of this protocol is to determine if an investigational drug is effective in treating nerve malfunction in diabetes.
Detailed Description
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Conditions
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Diabetic Neuropathies
Diabetes Mellitus
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Interventions
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Ruboxistaurin mesylate
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Patients must have type I or type II Diabetes Mellitus.
* Have been clinically diagnosed with neuropathy.
* Have an 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.
* Have been clinically diagnosed with neuropathy.
* Have an 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 in or are currently participating in a Medical study in which you receive an experimental drug.
* Are a woman and are pregnant or breastfeeding, intending to become pregnant within the next 2 years, or are a woman not using an effective method of birth control.
* Have poor kidney function.
* Drink an excess of alcohol or abuse drugs.
* Have recently participated in or are currently participating in a Medical study in which you receive an experimental drug.
* Are a woman and are pregnant or breastfeeding, intending to become pregnant within the next 2 years, or are a woman not using an effective method of birth control.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Mesa, Arizona, United States
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Irvine, California, United States
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Long Beach, 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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Norwalk, Connecticut, United States
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Clearwater, Florida, United States
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Plantation, Florida, United States
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Weston, Florida, United States
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Atlanta, Georgia, United States
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Idaho Falls, Idaho, United States
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North Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Boston, Massachusetts, United States
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Minneapolis, Minnesota, United States
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Columbia, Missouri, United States
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Omaha, Nebraska, United States
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Henderson, Nevada, United States
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Columbia, South Carolina, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, 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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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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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Halifax, Nova Scotia, Canada
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Toronto, Ontario, Canada
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Charlottetown, Prince Edward Island, Canada
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Laval, Quebec, Canada
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Zagreb, , Croatia
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Aarhus C, , Denmark
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Keila, , Estonia
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Tallinn, , Estonia
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Helsinki, , Finland
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Jyväskylä, , Finland
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Oulu, , Finland
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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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Gopālapuram, Chennai, India
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Bangalore, Karnataka, India
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Mumbai, Maharashtra, India
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Chennai, Tamil Nadu, India
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Kaunas, , Lithuania
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Klaipėda, , Lithuania
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Vilnius, , Lithuania
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Amersfoort, , Netherlands
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Santiago, La Coruna, Spain
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Dos Hermanas, Sevilla, Spain
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Madrid, , Spain
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Poole, Dorset, United Kingdom
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Salford, Manchester, United Kingdom
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Shrewsbury, Shropshire, United Kingdom
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Sheffield, South Yorkshire, United Kingdom
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Manchester, , United Kingdom
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United States
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Netherlands
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United Kingdom
Other Identifiers
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B7A-MC-MBBR
Identifier Type: -
Identifier Source: secondary_id
2784
Identifier Type: -
Identifier Source: org_study_id