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The Effect of Ruboxistaurin on Small Fiber Function

Sponsor
Chromaderm, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00190970
Collaborator
(none)
52
Enrollment
1
Location
13
Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine the effect of Ruboxistaurin on small fiber function.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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 Start Date :
Oct 1, 2004
Study Completion Date :
Nov 1, 2005

Outcome Measures

Primary Outcome Measures

  1. The objectives of this study is to evaluate the effect of ruboxistaurin on subjects with diabetic peripheral polyneuropathy []

Secondary Outcome Measures

  1. Ruboxistaurin will improve quantitative sensory testing and increase nerve fiber density in subjects with diabetic peripheral polyneuropathy. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
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

Sponsors and Collaborators

  • Chromaderm, Inc.

Investigators

  • Study Director: 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), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00190970
Other Study ID Numbers:
  • 7550
  • B7A-MC-MBDO
First Posted:
Sep 19, 2005
Last Update Posted:
Jul 26, 2016
Last Verified:
Jul 1, 2016
Additional relevant MeSH terms:
Diabetic Neuropathies
Ruboxistaurin

Study Results

No Results Posted as of Jul 26, 2016