The Effect of Ruboxistaurin on Small Fiber Function

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00190970
• Other study ID #: 7550
• Secondary ID: B7A-MC-MBDO
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: July 25, 2016
• Start date: October 2004
• Est. completion date: November 2005

Study information

• 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

Clinical Trial Summary

To determine the effect of Ruboxistaurin on small fiber function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 2005
• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy

Intervention

Drug:
• Ruboxistaurin

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Chromaderm, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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.