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The Effect of Ruboxistaurin on Small Fiber Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00190970
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : July 26, 2016
Information provided by:
Chromaderm, Inc.

Brief Summary:
To determine the effect of Ruboxistaurin on small fiber function.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathy Drug: Ruboxistaurin Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 52 participants
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 : October 2004
Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00190970

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United States, Virginia
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.
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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
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00190970    
Other Study ID Numbers: 7550
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action