Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Iloprost for Raynaud's Phenomenon Secondary to Systemic Sclerosis
iloprost
Vasculopathie Livedoïde+17
+ Maladies Cardiovasculaires
+ Maladies des Articulations
Étude thérapeutique
Résumé
Date de début de l'étude : 1 décembre 1995
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.200 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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