Back to resultsThe Effect of Ruboxistaurin on Small Fiber Function
Primary Purpose
Diabetic Neuropathy
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ruboxistaurin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathy
Eligibility 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.
Sites / Locations
- 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
Outcomes
Primary Outcome Measures
The objectives of this study is to evaluate the effect of ruboxistaurin on subjects with diabetic peripheral polyneuropathy
Secondary Outcome Measures
Ruboxistaurin will improve quantitative sensory testing and increase nerve fiber density in subjects with diabetic peripheral polyneuropathy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00190970
Brief Title
The Effect of Ruboxistaurin on Small Fiber Function
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Chromaderm, Inc.
4. Oversight
5. Study Description
Brief Summary
To determine the effect of Ruboxistaurin on small fiber function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
52 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ruboxistaurin
Primary Outcome Measure Information:
Title
The objectives of this study is to evaluate the effect of ruboxistaurin on subjects with diabetic peripheral polyneuropathy
Secondary Outcome Measure Information:
Title
Ruboxistaurin will improve quantitative sensory testing and increase nerve fiber density in subjects with diabetic peripheral polyneuropathy.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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
City
Norfolk
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17392551
Citation
Casellini CM, Barlow PM, Rice AL, Casey M, Simmons K, Pittenger G, Bastyr EJ 3rd, Wolka AM, Vinik AI. A 6-month, randomized, double-masked, placebo-controlled study evaluating the effects of the protein kinase C-beta inhibitor ruboxistaurin on skin microvascular blood flow and other measures of diabetic peripheral neuropathy. Diabetes Care. 2007 Apr;30(4):896-902. doi: 10.2337/dc06-1699.
Results Reference
derived
Learn more about this trial
The Effect of Ruboxistaurin on Small Fiber Function
We'll reach out to this number within 24 hrs