|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
8 August 2016 |
|
Main ID: |
NCT00044408 |
|
Date of registration:
|
28/08/2002 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes
|
|
Scientific title:
|
LY333531 Treatment of Symptomatic Peripheral Neuropathy in Patients With Diabetes |
|
Date of first enrolment:
|
July 2002 |
|
Target sample size:
|
200 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00044408 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Canada
|
Croatia
|
Finland
|
India
|
Lithuania
|
Netherlands
|
United Kingdom
|
United States
|
|
Contacts
|
|
Name:
|
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) |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Eli Lilly and Company |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Diabetic Neuropathies
|
|
Diabetes Mellitus, Non-Insulin-Dependent
|
|
Diabetes Mellitus, Insulin-Dependent
|
|
Intervention(s)
|
|
Drug: Ruboxistaurin mesylate
|
|
Primary Outcome(s)
|
|
Reduction in neuropathic symptoms
|
|
Secondary Outcome(s)
|
|
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
|
|
Secondary ID(s)
|
|
6204
|
|
B7A-MC-MBCW
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|