Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Iloprost for Raynaud's Phenomenon Secondary to Systemic Sclerosis

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Raynaud's phenomenon secondary to systemic sclerosis (SS) SS meets American College of Rheumatology diagnostic criteria At least 6 Raynaud's attacks per week --Prior/Concurrent Therapy-- No prior participation in oral iloprost study At least 4 weeks since participation in other investigational drug studies At least 2 months since prostanoid therapy At least 12 months since sympathectomy of upper limb Ongoing therapy for systemic sclerosis may continue on study Raynaud's therapy discontinued at entry --Patient Characteristics-- Hematopoietic: No platelet disorder Hepatic: No bleeding diathesis Renal: Creatinine clearance (estimated) at least 30 mL/min Cardiovascular: No unstable angina pectoris None of the following within 3 months: Stroke Transient ischemic attack Myocardial infarction Other: No active cancer or other uncontrolled disease No current history of alcohol or drug abuse No mental disorder precluding compliance No pregnant or nursing women Negative pregnancy test required of fertile women Adequate contraception required of fertile women