EUCTR2009-011577-32-IT进行中（未招募）不适用
Comparison between frovatriptan plus different treatment regimens of dexketoprofen (25 mg and 37.5 mg) and frovatriptan alone in the acute treatment of migraine without aura and migraine with aura attacks - ND
SOFARMACO0 个研究点开始时间: 2009年6月19日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 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
- •- Male or female subjects between 18-65 years of age - Subjects signing their Informed Consent at V-1 - Diagnosis of migraine with or without aura, meeting the criteria issued by the International Headache Society in 2001, published in 2003 - Frequency of 1 to 6 migraine attacks per month for at least 6 months prior to start of the study - Women of childbearing age must have a negative pregnancy test before inclusion in the study and they must use adequate contraceptive protection for all study duration (from the moment they sign their informed consent at V-1, until the end of the follow-up period).
- •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
- •- Diagnosis of typical aura with non-migraine headache, typical aura without headache, basilar migraine, hemiplegic migraine, opthalmoplegic migraine. - Coexistence of other headache types, in addition to migraine with aura or migraine without aura. - History of drug abuse in acute migraine attacks treatment (subjects taking drugs to treat acute migraine attacks for 10 or more days a month). - Use of prophylactic migraine attacks therapy in case dose has not been stable for at least three months before V0 (in case of stable dose, it must remain the same for all study duration). - Subjects that have taken antipsychotics or antidepressant drugs (unless they were taken as prophylaxis of migraine attacks) within the three months prior to V0. - Subjects that received anti-psychotic medication. - Subject taking ergotamine, ergotamine-derived (including methysergide), St John?s Wort (Hypericum perforatum), monoamine-oxidase inhibitors, NSAIDs (COX-2 inhibitors), oral corticosteroid, warfarin or other coumarins, Selective serotonin reuptake inhibitors, antiaggregant agents such as aspirin, heparin, lithium, methotrexate, idantoine and sulphonamides. - Subjects who meet DSM-IV criteria for alcohol/drug abuse or dependence. - Subjects allergic to IMP or similar drugs or with hypersensitivity to any ingredient of the trial drug composition. - Subjects with anamnesis of myocardial infarction, ischemic heart disease, coronary vasospasm, peripheral vascular disease, signs or symptoms suggesting ischemic heart disease. - Severe or moderately severe hypertension, or non controlled mild hypertension. - Previous cerebrovascular accident (CVA) or transient ischaemic attack (TIA). - Risk of coronary disease, including hard smokers or subjects following a nicotine substitute treatment, without a preliminary cardiovascular evaluation. - Subjects with familiar galactose intolerance, with lactase deficit or suffering from glucose-galactose malabsorption. - Liver pathology (AST or ALT >3 times greater than normal upper limit or total serum bilirubin >1.5 times greater than normal upper limit). - Renal insufficiency (serum creatinine >200 Omol/L or 2 mg/dL). - Subjects who have previously shown hypersensitivity reactions to NSAIDs (e.g., asthma, broncospasm, acute rhinitis, nasal polyp, urticaria, or angioneurotic edema). - Suspect or active peptic ulcer/bleeding or positive anamnesis for peptic ulcer/bleeding or chronic dyspepsia. - History of gastrointestinal bleeding or perforation related to NSAIDs therapies. - Subjects with gastrointestinal bleeding or other active bleeding, or blood coagulation diseases. - Crohn?s disease or ulcerous colitis. - Bronchial asthma. - Severe cardiac failure. - Bleeding diathesis or other coagulation disturbances. - Hemopoietic impairment, systemic lupus erythematosus or connective system pathologies. - Pregnancy or breast feeding. - Concurrent involvement in another investigational study or participation within 6 months prior to the start of this study (V0).
研究者
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FROVATRIPTAN VERSUS ZOLMITRIPTAN IN THE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA A PATIENT PREFERENCE STUDY - NDAmbulant male and non pregnant females aged 18 and 65 years with history of migraine according to the IHS criteria, having had at least one but not more than six episodes of migraine per month during the last 6 months.MedDRA version: 9.1Level: LLTClassification code 10027599Term: MigraineEUCTR2006-005764-81-ITSOFARMACO120
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