EUCTR2011-005603-32-DE进行中（未招募）1 期
se of acetylsalicylic acid (ASA) for enhanced early detection of colorectal neoplasms - K357, ASTER
German Cancer Research Center (DKFZ)0 个研究点开始时间: 2012年5月30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
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 40 to 80 years (both males and females; premenopausal women must have a negative pregnancy test before inclusion into the study, postmenopausal women are women who have not had menstrual bleeding for at least 12 months, or have been surgically sterilized)
- •Planned screening or diagnostic colonoscopy
- •Able to speak and understand German sufficiently to be able to give written informed consent and comply with the study requirements
- •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 2400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2400
排除标准
- •Factors potentially influencing the primary endpoint
- •Diseases/symptoms:
- •-Chronic inflammatory bowel disease (e.g. Crohn’s disease, colitis ulcerosa)
- •-Colonoscopy due to positive fecal occult blood test
- •-History of Colorectal cancer
- •-Angiodysplasia of the colon
- •-Anamnestic or observed blood loss per anum
- •Use of any of the following drugs Within 2 weeks before the study:
- •-Anticoagulants (including, but not limited to heparin, vitamin K antagonists [e.g. phenprocoumon, warfarin], direct thrombin inhibitors [e.g. dabigatran], or factor Xa inhibitors [apixapan, rivaroxaban])
- •-Antiplatelet drugs (e.g. clopidogrel, prasugrel, ticlopidin)
- •Within 1 week before the study
- •-Acetylsalicylic acid Within 3 days before the study
- •-NSAIDs and COX-2 inhibitors
- •-Factors potentially affecting the safety
- •-Any current clinically relevant signs and symptoms, including
- •-Signs and symptoms suggesting acute gastrointestinal ulcer
- •-Known clinically relevant thrombocytopenia
- •.Acute infection
- •-Volume deficit (exsiccosis)
- •-Any currently present allergy with dermal reactions, pruritus, or urticaria
- •-Severe or insufficiently controlled asthma
- •-Severe kidney or liver diseases (e.g. GFR <30 ml/min, liver cirrhosis)
- •-Severe, not sufficiently treated heart failure (as judged by the investigator)
- •-Severe, poorly controlled arterial hypertension
- •-Any other unclear symptoms needing further investigation in the opinion of the investigator
- •Any of the following anamnestic findings
- •-History of severe gastrointestinal bleeding
- •-Known hemorrhagic diathesis, including, but not limited to, hypoprothrombinaemia, severe thrombocytopenia, hemophilia
- •-Asthma, except for patients who have used acetylsalicylic acid in the past without negative effects
- •-Hypersensitivity against salicylic acid or other ingredients of the study drugs
- •-Previous intolerance to NSAIDs, COX-2 inhibitors, or antirheumatic medication
- •-Severe gout (e.g. recurrent attacks)
- •-Hereditary oxaluria
- •-Known G6PD or glutathione peroxidase deficiency
- •-Known epilepsy with generalised seizures
- •-Severe cardiac diseases (including, but not limited to, myocardial infarction in the past 6 months)
- •Intention to use any of the following drugs during the study:
- •-Anticoagulants
- •-Antiplatelet drugs
- •-NSAIDs, COX-2 inhibitors
- •-Methotrexate = 15 mg/week
- •-Systemic glucocorticoids
- •-Selective serotonin reuptake inhibitors (SSRIs)
- •-valproic acid
- •Planned surgery/dental treatment during participation in the study
- •Other factors
- •Known or suspected relevant alcohol abuse
- •Known or suspected illicit drug abuse
- •Suspected non-compliance with the study procedures
- •Participation in another clinical study
研究者
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