The Effect of Ruboxistaurin on Small Fiber Function
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.
2 other identifiers
interventional
52
1 country
1
Brief Summary
To determine the effect of Ruboxistaurin on small fiber function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2004
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedJuly 26, 2016
July 1, 2016
September 12, 2005
July 25, 2016
Conditions
Outcome Measures
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chromaderm, Inc.lead
Study Sites (1)
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
Related Publications (1)
Casellini CM, Barlow PM, Rice AL, Casey M, Simmons K, Pittenger G, Bastyr EJ 3rd, Wolka AM, Vinik AI. A 6-month, randomized, double-masked, placebo-controlled study evaluating the effects of the protein kinase C-beta inhibitor ruboxistaurin on skin microvascular blood flow and other measures of diabetic peripheral neuropathy. Diabetes Care. 2007 Apr;30(4):896-902. doi: 10.2337/dc06-1699.
PMID: 17392551DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 19, 2005
Study Start
October 1, 2004
Study Completion
November 1, 2005
Last Updated
July 26, 2016
Record last verified: 2016-07