Controlled Trial of 4-Aminosalicylic Acid in Patients With Small Bowel Crohn's Disease
-aminosalicylic acid
Enfermedades del Sistema Digestivo+5
+ Gastroenteritis
+ Enfermedades Intestinales
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, placebo controlled, multicenter study. Patients are randomized to receive either oral 4-aminosalicylic acid (4-ASA) or placebo twice a day for 12 weeks. After 12 weeks patients who improved with 4-ASA and those who received placebo are given the option of receiving 4-ASA for an additional year. Patients who were randomized to receive 4-ASA and continue treatment after 12 weeks are followed every 3 months for 1 year. Patients who were randomized to receive placebo and begin 4-ASA therapy after 12 weeks are followed monthly for 3 months, then every 3 months for 1 year. Completion date provided represents the completion date of the grant per OOPD records
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 80 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.De 18 a 80 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-- Active small bowel Crohn's disease established by clinical evaluation and prior radiologic study, endoscopy, surgical findings and/or histopathology Crohn's Disease Activity Index (CDAI) must be between 150 and 450 No ulcerative or infectious colitis or severe perianal disease --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: Stable dose of no greater than 20 mg per day of prednisone allowed Endocrine therapy: No immunosuppressive drugs within the past 3 months No concurrent immunosuppressive drugs Radiotherapy: Not specified Surgery: No impending surgery No prior ileostomy or colostomy Other: No 5-aminosalicylates within the past 2 weeks No concurrent 5-aminosalicylates No concurrent metronidazol or ciprofloxacin --Patient Characteristics-- Age: 18 to 80 Performance status: Ambulatory Hematopoietic: Not specified Hepatic: No hepatic disease Renal: No renal disease Other: Not pregnant (negative pregnancy test required) Fertile patients must use effective contraception No documented salicylate allergy