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Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes

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ClinicalTrials.gov Identifier: NCT00044395
Recruitment Status : Completed
First Posted : August 30, 2002
Last Update Posted : November 6, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this protocol is to determine if an investigational drug is effective in treating nerve malfunction in diabetes.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathies Diabetes Mellitus, Insulin-Dependent Diabetes Mellitus, Non-Insulin-Dependent Drug: Ruboxistaurin mesylate Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: LY333531 Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes
Study Start Date : July 2002
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Reduction in neuropathic symptoms

Secondary Outcome Measures :
  1. 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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00044395


  Show 39 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00044395     History of Changes
Other Study ID Numbers: 2133
B7A-MC-MBBP
First Posted: August 30, 2002    Key Record Dates
Last Update Posted: November 6, 2007
Last Verified: November 2007

Additional relevant MeSH terms:
Diabetes Mellitus
Peripheral Nervous System Diseases
Diabetic Neuropathies
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Autoimmune Diseases
Immune System Diseases
Ruboxistaurin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action