The Effect of Ruboxistaurin on Small Fiber Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-11-30

Brief Summary

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To determine the effect of Ruboxistaurin on small fiber function.

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Detailed Description

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Conditions

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Diabetic Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Ruboxistaurin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No