NCT01245465已完成1 期
Safety and Efficacy of Profermin® to Induce Remission in Patients With Ulcerative Colitis
Nordisk Rebalance A/S0 个研究点目标入组 39 人开始时间: 2009年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 主要终点
- Our primary endpoint was to estimate the proportion of patients with a reduction in SCCAI ≥50%.
研究概览
简要总结
In this study the investigators aim was to investigate the safety and possible efficacy of Profermin® in patients with ulcerative colitis. The investigators also aimed at assessing the usefulness of a new online daily symptom registration system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients were eligible if they were between 18 and 50 years of age and had an established diagnosis of UC based on clinical, endoscopic and histological features. Active disease was assessed by Simple Clinical Colitis Activity Index (SCCAI) (Table 1) score above 4 and below
排除标准
- •Patients who initiated treatment with azathioprine, 6-mercaptopurine, ciclosporin or methotrexate within 8 weeks prior to inclusion or TNF-α inhibitors within 12 weeks before inclusion or had changes in UC treatment within 2 weeks before inclusion were ineligible for the study. Concomitant coeliac disease or lactose intolerance were also exclusion criteria. In addition any malignant or premalignant condition or recent gastroenteritis rendered patients ineligible-
结局指标
主要结局
Our primary endpoint was to estimate the proportion of patients with a reduction in SCCAI ≥50%.
时间窗: 24 weeks
Daily report of SCCAI symptoms on the Internet
次要结局
- Our secondary endpoint was to estimate the proportion of patients in remission defined as SCCAI lower than or equal to 2.5(24 weeks)
研究者
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