EUCTR2006-002948-28-DE进行中（未招募）1 期
Prospective randomized monoinstitutional study of the treatment of therapy-associated diarrhea during percutaneous radiation therapy of the small pelvis. – Comparison of loperamide and tincture of opium - Loop- - Loop
MAROS Arzneimittel GmbH0 个研究点目标入组 200 人开始时间: 2006年8月23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
- 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
- •age = 18 years
- •patients who will undergo a percutaneous radiation therapy in the area of the small pelvis. This includes patients with following malignancies: rectal carcinoma, prostate carcinoma, endometrial carcinoma, cervix carcinoma.
- •Diarrhea grade 1 and grade 2 (Classification NCI-CTCAE Version 3.0)
- •ECOG-Grade 0-2
- •Enlightenment and written declaration of consent to the participation.
- •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
- •Pregnant patients or patients in lactation period.
- •Severe dysfunction of liver or kidneys
- •Injury or illness of brain e.g. increased intracranial pressure, cerebral arteriosclerosis
- •Hypersensitivity to components of loperamide or tincture of opium
- •Toxic megacolon
- •Pseudmembraneous colitis/ antibiotic-associated colitis
- •Diarrhea associated with fever and bloody stools
- •Acute increase of colitis ulcerosa or bacterial colitis caused by invasive pathogenes
- •Severe respiratory dysfunction or severely limited lung function e.g. bronchial asthma, bronchitis
- •Dysfunctional draining of biliary area, biliary colics.
- •Concomitant or earlier addiction of alcohol or opiates
- •Severe heart disease
- •Pheochromocytoma
- •Acute hepatic porphyria
- •Cor pulmonale
- •Morbus Addison
- •Severe hypothyreoidism
- •Organisational problems or circumstances which prevent a complete collection of required data
- •artificial anus
- •participation in a clinical trial within the last 30 days before inclusion
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