NCT00780507已完成不适用
Fecal Biomarker Study for Patients From a Once Daily Study for Efficacy in a Ulcerative Colitis Maintenance Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Compare the fecal biomarker calprotectin between the UC patients who relapse (flare) and the UC patients who remain in remission throughout the study while on Asacol regardless of the maintenance regimen.
研究概览
简要总结
The present study will analyze fecal levels of FC and FL in UC patients who relapse (flare) while on a QD or a BID Asacol treatment regimen and compare those levels to levels of FC and FL in UC patients who do not relapse (flare).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Be willing and able to provide written informed consent for this biomarker study;
- •Be enrolled in Study 2007021 (QDIEM).
排除标准
- •Meet the QDIEM Protocol 2007021 for Exclusion Criteria
结局指标
主要结局
Compare the fecal biomarker calprotectin between the UC patients who relapse (flare) and the UC patients who remain in remission throughout the study while on Asacol regardless of the maintenance regimen.
时间窗: one year
次要结局
- To compare the fecal levels of the 2 biomarkers (FC and FL) in patients who are on BID and QD treatment regimens and who remain in remission for the duration of the study;(one year)
研究者
研究点 (1)
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