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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00190970
Other study ID # 7550
Secondary ID B7A-MC-MBDO
Status Completed
Phase Phase 2
First received September 12, 2005
Last updated July 25, 2016
Start date October 2004
Est. completion date November 2005

Study information

Verified date July 2016
Source Chromaderm, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To determine the effect of Ruboxistaurin on small fiber function.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date November 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Ruboxistaurin


Locations

Country Name City State
United States 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

Sponsors (1)

Lead Sponsor Collaborator
Chromaderm, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The objectives of this study is to evaluate the effect of ruboxistaurin on subjects with diabetic peripheral polyneuropathy
Secondary Ruboxistaurin will improve quantitative sensory testing and increase nerve fiber density in subjects with diabetic peripheral polyneuropathy.
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