Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Iloprost for Raynaud's Phenomenon Secondary to Systemic Sclerosis
iloprost
Vasculopatía Livedoide+11
+ Enfermedades Cardiovasculares
+ Enfermedades de las Articulaciones
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de diciembre de 1995
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 200 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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