ISRCTN99666810已完成不适用
A randomised, open study of aminosalicylate withdrawal in patients with ulcerative colitis in established remission on combination treatment of azathioprine (or 6-mercaptopurine) and an aminosalicylate
niversity of Nottingham (UK)0 个研究点目标入组 410 人开始时间: 2008年1月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 410
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male and female patients aged between 18 and 75 years with ulcerative colitis
- •2. Patients whose ulcerative colitis has been in clinical remission, defined as being off steroids for 3 months or longer
- •3. Patients taking both azathioprine (or 6-mercaptopurine) and an aminosalicylate
- •4. Patients taking azathioprine (greater than 50 mg/day) or 6-mercaptopurine (greater than 25 mg/day) at a stable dose for at least 8 weeks
- •5. Patients taking an aminosalicylate at a stable dose (specified below) for at least 4 weeks:
- •5.1. Sulphasalazine greater than 1.5 g/day
- •5.2. Pentasa (slow release mesalazine) greater than 750 mg/day
- •5.3. Asacol (mesalazine) or generic equivalents greater than 800 mg/day
- •5.4. Colazide (balsalazide) greater than 2.25 g/day
- •5.5. Dipentum (olsalazine) greater than 750 mg/day
- •6. Patients on combined treatment with azathioprine (or 6-MP) and an aminosalicylate for a minimum of 6 months but no more than 4 years without relapse. Patients may enter if they have briefly been off either treatment during this time (e.g., because of abnormal blood test results) but prescription of each drug should cover at least 85% of the period of time for continuous drug treatment to be declared. N.B. Duration of aminosalicylate may be longer.
- •7. Patients who have given written informed consent
排除标准
- •1. Patients with Crohn?s disease
- •2. Patients with a baseline Walmsley Simple Activity Index greater than 2
- •3. Patients with a baseline sigmoidoscopy grade of greater than 2 (Baron Scale)
- •4. Patients requiring long term treatment with oral steroids for any medical condition
- •5. Women who are pregnant or lactating
- •6. Patients with known human immunodeficiency virus (HIV) infection
- •7. Other serious medical or psychiatric illness currently ongoing, or experienced within the past three months, that in the opinion of the investigator would compromise the study
- •8. Patients unable to comply with the protocol requirements, including severe alcohol and drug use
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