Controlled Trial of 4-Aminosalicylic Acid in Patients With Small Bowel Crohn's Disease
-aminosalicylic acid
Maladies du système digestif+7
+ Gastroentérite
+ Maladies intestinales
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, 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
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.80 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.De 18 à 80 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-- 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