A Rho-Kinase Inhibitor (Fasudil) in the Treatment of Raynaud's Phenomenon - Full Text View

Purpose

Raynaud's phenomenon is thought to occur when, in response to cold or emotional stress, there is closure of the digital arteries and cutaneous arterioles leading to the clinical finding of sharp demarcated digital pallor and cyanosis of the distal skin of the fingers and/or toes. Patients often continue to experience problems despite current available treatment. Our study will investigate the use of a new vasodilator called Fasudil, a Rho-kinase inhibitor. Our hypothesis is that Fasudil will prevent vasoconstriction of digital and cutaneous arteries during a standard laboratory based cold exposure and will therefore improve digital blood flow and skin temperature recovery time following cold challenge. These data will provide the rationale for a more elaborate clinical trials in real life situations.

Condition	Intervention	Phase
Raynaud's	Drug: Fasudil	Phase III

ChemIDplus related topics:

Fasudil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	Efficacy, Tolerability and Biology of a Rho-Kinase Inhibitor (Fasudil) in the Treatment of Raynaud's Phenomenon

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

The time to recover 50% and 70% of fall in the baseline skin temperature. [ Time Frame: within 60 minutes following cold challenge ]

Secondary Outcome Measures:

- The blood flow profile changes as determined by Laser Doppler scans of the fingers [ Time Frame: within the time frame of the cold challenge recovery period ]

Estimated Enrollment:	24
Study Start Date:	April 2007
Estimated Study Completion Date:	July 2007

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of scleroderma
Definite Raynaud's

Exclusion Criteria:

symptomatic orthostatic hypotension
evidence of current malignancy
active ischemic digital ulcer and/or tissue gangrene
history of sympathectomy at any time
upper extremity deep vein thrombosis or lymphedema within 3 months of the study
recent surgical procedure requiring general anesthesia
current alcohol or illicit drug use
use of any investigational drug within 30 days of the study sessions
pregnancy or current breast feeding
subjects felt by the investigators to active disease that would affect their ability to safely participate in the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498615

Contacts


Contact: Regina Greco, R.N.	410-550-2629	rniedzw1@jhmi.edu

Contact: Pam S Hill	410-550-2003	ph@jhmi.edu

Locations


United States, Maryland
	Johns Hopkins University	Recruiting
	Baltimore, Maryland, United States, 21224
	Contact: Fredrick M Wigley, M.D. 410-550-2003 ph@jhmi.edu
	Principal Investigator: Fredrick M Wigley, M.D.

Sponsors and Collaborators

Johns Hopkins University

Investigators


Principal Investigator:	Fredrick M Wigley, M.D.	Johns Hopkins University

More Information

Study ID Numbers:	NA_00002801
First Received:	July 6, 2007
Last Updated:	July 10, 2007
ClinicalTrials.gov Identifier:	NCT00498615
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:

scleroderma

Raynaud's phenomenon

Rho-kinase inhibitor

Study placed in the following topic categories:

Peripheral Vascular Diseases

Raynaud Disease

Vascular Diseases

Fasudil

Additional relevant MeSH terms:

Membrane Transport Modulators

Vasodilator Agents

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Calcium Channel Blockers

Enzyme Inhibitors

Cardiovascular Diseases

Cardiovascular Agents

Protein Kinase Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	Johns Hopkins University
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00498615