A Rho-kinase Inhibitor (Fasudil) in the Treatment of Raynaud's Phenomenon
Condition: Raynaud; Scleroderma
MeSH terms: Raynaud Disease; Scleroderma, Systemic; Scleroderma, Diffuse
Intervention: Fasudil
Intervention description: Each subject will be randomly assigned to 1 of 6 possible treatment sequences (ABC, ACB, BAC, BCA, CAB, and CBA) in a double-blind manner: A- a single oral dose of 2 placebo tablets; B- a single, oral 40 mg Fasudil dose as one 40 mg tablet and 1 placebo tablet; C- a single oral 80 mg dose as two 40 mg Fasudil tablets. Subjects will be randomized at the screening/baseline visit to a specific treatment sequence based upon a computer generated code on a 1:1:1:1:1:1 ratio for the 6 possible sequences. A single dose consisting of the two tablets will be taken after fasting for 10 hours once during each treatment period. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods. Concomitant medications will not be taken during the study session.
Intervention MeSH terms: Fasudil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: scleroderma; Raynaud's phenomenon; Rho-kinase inhibitor

Summary:

      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. The
      investigators' study will investigate the use of a new vasodilator called Fasudil, a
      Rho-kinase inhibitor. The investigators' 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.
    

Eligibility 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.