Back to resultsTreatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes
Primary Purpose
Diabetic Neuropathies, Diabetes Mellitus, Insulin-Dependent, Diabetes Mellitus, Non-Insulin-Dependent
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ruboxistaurin mesylate
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathies
Eligibility 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.
Sites / 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) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00044408
Brief Title
Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes
Official Title
LY333531 Treatment of Symptomatic Peripheral Neuropathy in Patients With Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chromaderm, Inc.
4. Oversight
5. Study Description
Brief Summary
The purpose of this protocol is to determine if an investigational drug known as LY333531 is effective in treating nerve malfunction in diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies, Diabetes Mellitus, Insulin-Dependent, Diabetes Mellitus, Non-Insulin-Dependent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ruboxistaurin mesylate
Primary Outcome Measure Information:
Title
Reduction in neuropathic symptoms
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Long Beach
State/Province
California
Country
United States
Facility Name
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City
Norwalk
State/Province
Connecticut
Country
United States
Facility Name
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City
Clearwater
State/Province
Florida
Country
United States
Facility Name
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City
Plantation
State/Province
Florida
Country
United States
Facility Name
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City
Idaho Falls
State/Province
Idaho
Country
United States
Facility Name
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City
North Chicago
State/Province
Illinois
Country
United States
Facility Name
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City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
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City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
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City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
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City
Columbia
State/Province
Missouri
Country
United States
Facility Name
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City
New York
State/Province
New York
Country
United States
Facility Name
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City
Columbia
State/Province
South Carolina
Country
United States
Facility Name
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City
San Antonio
State/Province
Texas
Country
United States
Facility Name
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City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
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City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
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City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
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City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
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City
Charlottetown
State/Province
Prince Edward Island
Country
Canada
Facility Name
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City
Laval
State/Province
Quebec
Country
Canada
Facility Name
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City
Zagreb
Country
Croatia
Facility Name
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City
Helsinki
Country
Finland
Facility Name
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City
Jyvaskyla
Country
Finland
Facility Name
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City
Oulu
Country
Finland
Facility Name
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City
Gopalapuram
State/Province
Chennai
Country
India
Facility Name
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City
Mumbai
State/Province
Maharashtra
Country
India
Facility Name
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City
Hyderabad
Country
India
Facility Name
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City
Kaunas
Country
Lithuania
Facility Name
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City
Klaipeda
Country
Lithuania
Facility Name
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City
Vilnus
Country
Lithuania
Facility Name
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City
Amersfoort
Country
Netherlands
Facility Name
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City
Poole
State/Province
Dorset
Country
United Kingdom
Facility Name
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City
Salford
State/Province
Manchester
Country
United Kingdom
Facility Name
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City
Shrewsbury
State/Province
Shropshire
Country
United Kingdom
Facility Name
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City
Sheffield
State/Province
South Yorkshire
Country
United Kingdom
Facility Name
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City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes
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