NL-OMON32538已完成3 期
Multicentre, controlled, randomised, investigator-blinded, comparative study of oral Mesalazine 4g per day Once daily versus 4g per day in Two divided doses in patients with active Ulcerative colitiS (MOTUS study) - MOTUS
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ferring
- 入组人数
- 40
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Male and female patients, aged over 18 years.
- •Active mild to moderate ulcerative colitis (new or relaps) with disease extension beyond rectum
- •at least one total colonoscopy in their disease history (within the previous 5 years.
- •UC-DAI score 3-8.
- •Women with childbearing potential must be using a contraceptive method judged effective by the investigator.
- •Oral maintenance treatment with azathioprine or 6-mercaptopurine (taken for at least 6 months at stable dose and continued at the same dose throughout the study) is permitted.
排除标准
- •Previous colonic surgery.
- •Previously failed to respond to steroids within the previous year.
- •Non-response to rectal 5-ASA therapy or to oral 5-ASA therapy at a dose > 3/day for induction of remission within the previous year.
- •Current relapse lasting more than 6 weeks.
- •Pregnancy or breast-feeding.
研究者
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