EUCTR2006-002036-25-GB进行中（未招募）1 期
Epidermal growth factor enemas versus mesalazine enemas for the treatment of mild-to-moderate active left-sided ulcerative colitis or proctitis - EGF enema in UC
niversity Hospitals of Leicester NHS Trust0 个研究点目标入组 50 人开始时间: 2012年2月15日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) male and female participants above age of 18 with a definite diagnosis of ulcerative colitis or proctitis.
- •2) mild-to-moderate disease activity with a UC disease activity index score between 3 and 8.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) patients with infectious colitis.
- •2) colonic inflammation extending proximal to the left colon (i.e. beyond the splenic flexure on sigmoidoscopic examination).
- •3) Patients receiving oral maintenance therapy with a total daily dose of >3g of mesalazine within 30days prior to study entry.
- •4) use of any immunosuppressive agent within 90days prior to study.
- •5) intake of corticosteroids (orally or rectally) within 7days prior to entry.
- •6) chronic use of non-steroidal anti-inflammatory drugs in 7 days prior to inclusion (chronic use defined as drug intake for a minimum of 7 consecutive days).
- •7) presence of severe renal / hepatic impairment, malignant disease and allergies to salicylates.
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