The Effect of Ruboxistaurin on Small Fiber Function

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the effect of Ruboxistaurin on small fiber function.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chromaderm, Inc.
• Treatments: Ruboxistaurin

Criteria

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.