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Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00044408
First received: August 28, 2002
Last updated: November 5, 2007
Last verified: November 2007
History of Changes

August 28, 2002
November 5, 2007
July 2002
Not Provided
Reduction in neuropathic symptoms
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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
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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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Diabetic Neuropathies
  • Diabetes Mellitus, Insulin-Dependent
  • Diabetes Mellitus, Non-Insulin-Dependent
Drug: Ruboxistaurin mesylate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
October 2005
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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
Not Provided
Not Provided
Eli Lilly and Company
Not Provided
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP