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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/NCT00044421




Registration number
NCT00044421
Ethics application status
Date submitted
28/08/2002
Date registered
30/08/2002
Date last updated
6/11/2007

Titles & IDs
Public title
Treatment of Peripheral Neuropathy in Patients With Diabetes
Scientific title
LY333531 Treatment of Peripheral Neuropathy in Patients With Diabetes
Secondary ID [1] 0 0
B7A-MC-MBBR
Secondary ID [2] 0 0
2784
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Neuropathies 0 0
Diabetes Mellitus 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 the progression of DPN measured by composite score
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Vibration sensation;Electrophysiology of tibial, peroneal and sural nerves;Neurological signs;Neuropathic symptoms;Clinical global impression of change;Health outcome measures
Timepoint [1] 0 0

Eligibility
Key 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.
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 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.

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
1/10/2006
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) Mon-Fri from 9AM to 5PM 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) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - St. Leonards
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) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Caulfield
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) Mon-Fri from 9AM to 5PM 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
- St. Leonards
Recruitment postcode(s) [3] 0 0
- Caulfield
Recruitment postcode(s) [4] 0 0
- Clayton
Recruitment outside Australia
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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/NCT00044421
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1977-285-4559) or 1317-615-4559 Mon-Fri 9 AM - 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