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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00044395




Registration number
NCT00044395
Ethics application status
Date submitted
28/08/2002
Date registered
30/08/2002
Date last updated
6/11/2007

Titles & IDs
Public title
Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes
Scientific title
LY333531 Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes
Secondary ID [1] 0 0
B7A-MC-MBBP
Secondary ID [2] 0 0
2133
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Neuropathies 0 0
Diabetes Mellitus, Insulin-Dependent 0 0
Diabetes Mellitus, Non-Insulin-Dependent 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ruboxistaurin mesylate

Treatment: Drugs: Ruboxistaurin mesylate
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Reduction in neuropathic symptoms
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2005
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
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 - Camperdown
Recruitment hospital [2] 0 0
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 - Randwick
Recruitment hospital [3] 0 0
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 - St Leonards
Recruitment hospital [4] 0 0
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 - Caulfield
Recruitment hospital [5] 0 0
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 - Clayton
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Randwick
Recruitment postcode(s) [3] 0 0
- St Leonards
Recruitment postcode(s) [4] 0 0
- Caulfield
Recruitment postcode(s) [5] 0 0
- Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
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United States of America
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Indiana
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United States of America
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Nebraska
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United States of America
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Nevada
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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Texas
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United States of America
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Vermont
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United States of America
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Virginia
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United States of America
State/province [15] 0 0
West Virginia
Country [16] 0 0
Belgium
State/province [16] 0 0
Edegem
Country [17] 0 0
Belgium
State/province [17] 0 0
Huy
Country [18] 0 0
Belgium
State/province [18] 0 0
Willebroeck
Country [19] 0 0
Denmark
State/province [19] 0 0
Aarhus C
Country [20] 0 0
Estonia
State/province [20] 0 0
Keila
Country [21] 0 0
Estonia
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Tallinn
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Germany
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Dresden
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Germany
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Dusseldorf
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Germany
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Mainz
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Hungary
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Budapest
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Hungary
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Debrecen
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Israel
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Jerusalem
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Spain
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La Coruna
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Spain
State/province [29] 0 0
Sevilla
Country [30] 0 0
Spain
State/province [30] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this protocol is to determine if an investigational drug is effective in
treating nerve malfunction in diabetes.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00044395
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00044395