The Effect of Ruboxistaurin on Small Fiber Function

Phase 2

Completed

• Conditions: Diabetic Neuropathy

• Registration Number: NCT00190970
• Lead Sponsor: Chromaderm, Inc.

Brief Summary

To determine the effect of Ruboxistaurin on small fiber function.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Completion: 2005-11
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-25
• Last Update Posted: 2016-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The objectives of this study is to evaluate the effect of ruboxistaurin on subjects with diabetic peripheral polyneuropathy

Secondary Outcome Measures

Name	Time	Method
Ruboxistaurin will improve quantitative sensory testing and increase nerve fiber density in subjects with diabetic peripheral polyneuropathy.

Trial Locations

Locations (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