EUCTR2008-000133-22-IT进行中（未招募）不适用
Efficacy and safety study of the antihistamine V0114CP 2.5mg in the treatment of seasonal allergic rhinitis randomized, double-blind, three arm parallel group study including placebo and active control arm (desloratadine 5 mg) - ND
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 900
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
- •- over 18 year-old male or female ambulatory patient, - suffering from seasonal allergic rhinitis to grass pollen, defined as: - a documented medical history of seasonal rhinitis during the grass pollen season (mainly May to July) with symptoms (sneezing and/or palate itching and/or aqueous rhinorrhoea and/or nasal blockade) for at least 2 years; if, for new patient, the medical history has never been documented, the diagnosis will be assessed by the score for allergic rhinitis (SFAR), - a positive skin prick test at selection visit or duly documented in the medical file in the last 6 months, at least to grass pollen grains, - with a nasal symptomatology score rated by the patient equal or superior at 6 at inclusion (max. score 12). - willing and able to understand and sign an approved Informed Consent Form, - able to understand the protocol and to attend the control visits, - if required by national regulation, registered with a social security or health insurance system. For women of child bearing potential: - use of an efficient contraceptive (implants, injectables, combined oral contraceptives, some intra-uterine devices or vasectomised partner related to note 3 of CPMP/ICH/286/95) for at at least 2 months before the study and one month after the end of study, -negative urine pregnancy test.
- •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
- •* Criteria related to pathologies -Any cardio-vascular, renal, hepatic, gastro-intestinal, endocrine, haematological, neuro-psychiatric severe diseases that will not be compatible with the participation to the study in the opinion of the investigator, -any acute or chronic disease that will not allow with the participation to the study in the opinion of the investigator, -asthma requiring a corticosteroid treatment, -chronic alcoholism, -history of agranulocytosis, -congenital galactosemia, malabsorption syndrom to glucose or galactose, or lactase deficiency, -seizure, -iatrogenic rhinitis, -nasal polyposis or severe deviation of the nasal septum, -history of nasal surgery within the last 6 months, -acute or chronic rhinosinusitis, as stated by the epidemiological definition of the EP3OS guideline, -upper respiratory tract infection within the last 3 weeks. *Criteria related to treatments -medical history of hypersensitivity to mequitazine or drug exvipients, -specific desensitization to grass pollen finished within the last 6 months, whatever the issue, -depot corticosteroid treatment within the last 6 months, -oral,injectable (intramuscular, intravenous, intraarticular, intraspinal) corticosteroid treatment within the last 4 weeks, -nasal or ocular corticosteroid treatment within the last 4 weeks, -treatment by antileukotriene within the last 7 days, -treatment by cromone or ketotifen within the last 2 weeks, -treatment by antihistamine within the last 7 days, by loratadine within the last 10 days, -treatment by NSAIDs (other than oxicams) within the last 3 days, -tratment by oxicams within the last 7 days, -regular treatment by nasal or oral decongetsive drug within the last 7 days, -treatment by tricyclic antidepressants (wash-out 4 weeks), MAO inhibitors (wash-out 4 weeks), atropine-like drugs (wash-out 4 weeks). *Criteria related to the population -lenght of QTc interval>450 ms, -planned travel outside the study area for a substantial portion of the study period, -participation to another clinical trial in the previous month or during the study, -patient who, in the judgement of the investigator is not likely to be compliant during the study, - patient who has fofeited his(her freedom by administrative or legal award, or who is under guardianship, -subject who cannot be contacted in case of emergency. For women childbearing potential: -pregnancy of breast feeding.
研究者
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