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Completed

NCT Number: NCT00190970

The Effect of Ruboxistaurin on Small Fiber Function

To determine the effect of Ruboxistaurin on small fiber function.

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Key information

Conditions

Diabetic Neuropathy Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ruboxistaurin

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Chromaderm, Inc.

Industry

Registry information

Official study 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.

Important dates

Study start
2004
Study completion
2005
First posted
Sep 19, 2005
Registry last updated
Jul 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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