Diabetic Neuropathy Clinical Trial
Official title:
The Effect of Ruboxistaurin Mesylate (LY333531) on Small Fiber Function as Measured by Microvascular Skin Blood Flow, C-Fiber Quantitations in Skin and Quantitative Sensory Testing of Cold and Heat.
Verified date | July 2016 |
Source | Chromaderm, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
To determine the effect of Ruboxistaurin on small fiber function.
Status | Completed |
Enrollment | 52 |
Est. completion date | November 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients must have Type 1 or Type 2 diabetes mellitus - Patients must have bilateral sensorimotor distal peripheral neuropathy attributable to diabetes mellitus - Patients must have blood glucose control measured as HbA1c=<11% - Patients must be 18 years of age or older. - Patients must be able to return to all follow-up visits Exclusion Criteria: - Patients must not have symptoms of diabetic peripheral neuropathy that cannot be distinguished from other etiologies - Patients must not have a neurologic disease or neuropathy from a cause other than diabetes mellitus that would interfere with correct evaluation of symptomatic peripheral neuropathy. - Patient currently has uncontrolled high blood pressure - You have other medical problems that your doctor feels would make it unsafe for you to participate in this study such as liver or kidney problems - You are a woman of childbearing age and unwilling or unable to use effective contraceptive. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Norfolk | Virginia |
Lead Sponsor | Collaborator |
---|---|
Chromaderm, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The objectives of this study is to evaluate the effect of ruboxistaurin on subjects with diabetic peripheral polyneuropathy | |||
Secondary | Ruboxistaurin will improve quantitative sensory testing and increase nerve fiber density in subjects with diabetic peripheral polyneuropathy. |
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