Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes

NCT ID: NCT00044395

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2005-10-31

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, Insulin-Dependent Diabetes Mellitus, Non-Insulin-Dependent

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 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.
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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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

Site Status

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Irvine, California, United States

Site Status

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Los Angeles, California, United States

Site Status

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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

Site Status

Countries

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United States Australia Belgium Denmark Estonia Germany Hungary Israel Spain

Other Identifiers

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B7A-MC-MBBP

Identifier Type: -

Identifier Source: secondary_id

2133

Identifier Type: -

Identifier Source: org_study_id