EUCTR2019-001916-44-AT进行中(未招募)1 期
A multicenter, randomized, doubleblind placebo controlled trial ofMicronized purified Flavonoid-Fraction (MPFF) in the managementof radiation proctitis - MiFlaPRO
Medical University Innsbruck, Department of Visceral, Transplant und Thoracic Surgery0 个研究点目标入组 200 人开始时间: 2020年1月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 200
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
- •signed informed consent form
- •male and female patients
- •age = 18 years
- •patients with diagnosis of radiation proctitis with macroscopic bleeding
- •end of radiotherapiy >= 3 month = 90 days
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •infectious proctitis
- •ulcerative proctitis (inflammatory bowel disease)
- •persons unable to understand the informed consent
- •persons, who are in dependent relationship with the study investigators
- •pregnant or lactating women
- •participation in an interventional study
研究者
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