| August 28, 2002 |
| November 5, 2007 |
| July 2002 |
| |
| Reduction in neuropathic symptoms |
| - Reduction in neuropathic symptoms |
| Complete list of historical versions of study NCT00044408 on ClinicalTrials.gov Archive Site |
| 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 |
- - 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
|
| |
| Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes |
| LY333531 Treatment of Symptomatic Peripheral Neuropathy in Patients With Diabetes |
The purpose of this protocol is to determine if an investigational drug known as LY333531 is effective in treating nerve malfunction in diabetes. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
- Diabetic Neuropathies
- Diabetes Mellitus, Insulin-Dependent
- Diabetes Mellitus, Non-Insulin-Dependent
|
| Drug: Ruboxistaurin mesylate |
| |
| |
| |
| Completed |
| 200 |
| October 2005 |
|
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.
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Canada, Croatia, Finland, India, Lithuania, Netherlands, United Kingdom |
| |
| NCT00044408 |
|
| 6204, B7A-MC-MBCW |
| Eli Lilly and Company |
|
| Study Director: |
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) |
Eli Lilly and Company |
|
|
| Eli Lilly and Company |
| November 2007 |