A Rho-kinase Inhibitor (Fasudil) in the Treatment of Raynaud's Phenomenon

PHASE3CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

April 30, 2007

Primary Completion Date

March 31, 2012

Study Completion Date

March 31, 2012

Conditions
RaynaudScleroderma
Interventions
DRUG

Fasudil

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.

Trial Locations (1)

21224

Johns Hopkins University, Baltimore

All Listed Sponsors
lead

Johns Hopkins University

OTHER

NCT00498615 - A Rho-kinase Inhibitor (Fasudil) in the Treatment of Raynaud's Phenomenon | Biotech Hunter | Biotech Hunter