跳至主要内容
临床试验/EUCTR2019-001916-44-AT
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

发起方
Medical University Innsbruck, Department of Visceral, Transplant und Thoracic Surgery

相似试验

进行中(未招募)
不适用
A multicenter randomized, double-blind placebo controlled phase III study of the efficacy of Xaliproden in preventing the neurotoxicity of oxaliplatin in first-line treatment of patients with metastatic colorectal cancer treated with oxaliplatin/5FU/LV
EUCTR2005-002570-30-ITSANOFI-SYNTHELABO900
进行中(未招募)
不适用
A multicenter, randomized double-blind placebo controlled Phase III study of the efficacy of xaliproden in preventing the neurotoxicity of oxaliplatin in first-line treatment of patients with metastatic colorectal cancer treated with oxaliplatin/5-FU/LV. - NA
EUCTR2005-002570-30-DEsanofi-aventis recherche & développement900
进行中(未招募)
不适用
A multicenter, randomized double-blind placebo controlled Phase III study of the efficacy of xaliproden in preventing the neurotoxicity of oxaliplatin in first-line treatment of patients with metastatic colorectal cancer treated with oxaliplatin/5-FU/LV. - NAPatients with metastatic colorectal cancer treated with oxaliplatin/5-FU/LVat risk of cumulative peripheral sensory neuropathy (PSN) relative to cumulative dose of oxaliplatin.MedDRA version: 8Level: LLTClassification code 10034620
EUCTR2005-002570-30-PTSanofi-Synthelabo Recherche900
进行中(未招募)
1 期
A multicenter, randomized double-blind placebo controlled Phase III study of the efficacy of xaliproden in preventing the neurotoxicity of oxaliplatin in first-line treatment of patients with metastatic colorectal cancer treated with oxaliplatin/5-FU/LV. - NA
EUCTR2005-002570-30-HUSanofi-Synthelabo Recherche900
进行中(未招募)
1 期
A multicenter, randomized double-blind placebo controlled Phase III study of the efficacy of xaliproden in preventing the neurotoxicity of oxaliplatin in first-line treatment of patients with metastatic colorectal cancer treated with oxaliplatin/5-FU/LV. - NA
EUCTR2005-002570-30-GBSanofi-Synthelabo Recherche900