Controlled Trial of 4-Aminosalicylic Acid in Patients With Small Bowel Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
研究概览
简要总结
OBJECTIVES:
I. Assess the efficacy and safety of 4-aminosalicylic acid in patients with active Crohn's disease of the small bowel.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供