Oral Iloprost for Raynaud's Phenomenon Secondary to Systemic Sclerosis
iloprost
Livedoid Vasculopathy+17
+ Cardiovascular Diseases
+ Joint Diseases
Treatment Study
Summary
Study start date: December 1, 1995
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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