Raynaud Disease, Systemic Sclerosis
Conditions
Keywords
Raynaud's syndrome, arthritis & connective tissue diseases, cardiovascular and respiratory diseases, rare disease, systemic sclerosis
Brief summary
OBJECTIVES: I. Evaluate the safety and efficacy of oral iloprost, a prostacyclin analog, in patients with Raynaud's phenomenon secondary to systemic sclerosis.
Detailed description
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution and digital cutaneous ulcers. Patients receive oral iloprost or placebo twice daily for 6 weeks. Thrombolytic drugs, oral anticoagulants, and heparin are prohibited on study. Concurrent therapy with angiotensin-converting enzyme inhibitors for Raynaud's is prohibited; calcium channel blockers for severe digital ischemia are allowed as needed. Patients are followed at 2 and 6 weeks.
Interventions
DRUGiloprost
Sponsors
University of Pittsburgh
National Center for Research Resources (NCRR)
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Outcome results
None listed