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The Effect of Ruboxistaurin on Small Fiber Function

This study has been completed.
Information provided by:
Chromaderm, Inc. Identifier:
First received: September 12, 2005
Last updated: July 25, 2016
Last verified: July 2016
To determine the effect of Ruboxistaurin on small fiber function.

Condition Intervention Phase
Diabetic Neuropathy Drug: Ruboxistaurin Phase 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Chromaderm, Inc.:

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.

Estimated Enrollment: 52
Study Start Date: October 2004
Estimated Study Completion Date: November 2005

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00190970

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.
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
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00190970     History of Changes
Other Study ID Numbers: 7550
Study First Received: September 12, 2005
Last Updated: July 25, 2016

Additional relevant MeSH terms:
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 processed this record on August 17, 2017