Oral 5-aminosalicylic Acid Withdrawal in Long Standing Inactive Ulcerative Colitis: A Double-blind, Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- The differences of relapse rates between the two arms
研究概览
简要总结
The purpose of this study is to determine whether aminosalicylic acid (ASA) can be safely withdrawn in patients with long-standing clinical inactive UC.
详细描述
This is a randomized, double-blind, controlled trial in which patients with long-standing clinically inactive UC receiving ASA for maintenance of remission will be randomized to either continue 5-ASA or to receive an equivalent placebo for 12 months. The primary endpoint is clinical relapse at 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have a confirmed diagnosis of UC according to established clinical, endoscopic and histologic criteria
- •in long-standing clinical remission
- •written informed consent
排除标准
- •allergic to mesalazine
- •prior bowel surgery except appendectomy
- •hepatic or renal dysfunction
- •malignant disease within 5 years
- •pregnancy or breast feeding or women of child-bearing age without regular use of contraception
- •on anti-tumor necrosis factor therapy
- •terminal illness
研究组 & 干预措施
Mesalazine
mesalazine 2g od po for 12 months
干预措施: Mesalazine (Drug)
Placebo oral capsule
placebo 5 capsules od po for 12 months
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
The differences of relapse rates between the two arms
时间窗: 12 months
Relapse rate of patient in both arms will be calculated
次要结局
- Patients' drug compliance(12 months)
研究者
Siew Chien NG
Professor
Chinese University of Hong Kong