EUCTR2006-005764-81-IT进行中（未招募）不适用
FROVATRIPTAN VERSUS ZOLMITRIPTAN IN THE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA A PATIENT PREFERENCE STUDY - ND
SOFARMACO0 个研究点目标入组 120 人开始时间: 2007年4月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
- •1. ambulant male and non pregnant female subjects; 2. 18 and 65 years of age at the randomisation visit; 3. with a current history of migraine with or without aura according to the IHS criteria; 4. having experienced an average of at least one but not more than six migraine attacks per month for 6 months prior to entry into the study; 5. willing and able to understand and complete the anticipated study questionnaires; 6. willing and able to sign the informed consent prior to entry into the study.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. history suggestive of ischaemic heart disease IHD; e.g. myocardial infarction, angina pectoris, coronary vasospasm, vasospastic Prinzmetal s variant angina or any atherosclerotic disease e.g. peripheral vascular disease indicating an increased risk of coronary ischaemia; 2. symptomatic Wolff-Parkinson-White syndrome or cardiac arrhythmias associated with other cardiac accessory conduction pathway disorders; 3. history of stroke or transient ischaemic attack TIA ; 4. uncontrolled hypertension; 5. history of basilar, hemiplegic or ophthalmoplegic migraine; 6. chronic cephalea; 7. severe liver impairment i.e., Child-Pugh 8805;7 ; 8. severe renal impairment i.e., CrCl 26 ml/min , renal disease, or renal failure; 9. known or suspected intolerance of, or hypersensitivity or contraindications to any component of the trial medications, including inert substances e.g. intolerance to galactose, Lapp s lactase deficiency, malabsorption of glucose-galactose, phenylketonuria ; 10. use of either test medication in the last month; 11. history of intolerance or inefficacy of at least two different triptans taken in a correct way for the treatment of migraine attacks; 12. current use of ergotamine or its derivatives as a prophylactic agent; 13. current use or use within the last 2 weeks of MAO-inhibitors; 14. use as a prophylactic agent of amitriptilina with dose 25 mg/die; 15. abuse of alcohol, analgesics or psychotropic drugs; 16. any severe concurrent medical condition that, according to the site Investigator, may affect the interpretation of clinical trial results; 17. pregnancy or breastfeeding; females or childbearing potential not using an effective form of contraception; 18. participation in a clinical trial, currently or within the previous month; 19. inability or unwillingness to issue the informed consen.
研究者
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