Status:
COMPLETED
The Effect of Ruboxistaurin on Small Fiber Function
Lead Sponsor:
Chromaderm, Inc.
Conditions:
Diabetic Neuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To determine the effect of Ruboxistaurin on small fiber function.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00190970
Start Date
October 1 2004
End Date
November 1 2005
Last Update
July 26 2016
Active Locations (1)
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1
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, United States