EUCTR2008-000133-22-BG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. RANDOMISED, DOUBLE-BLIND, THREE ARM PARALLEL GROUP STUDY INCLUDING PLACEBO AND ACTIVE CONTROL ARM (DESLORATADINE 5 MG)
Pierre Fabre Médicament0 个研究点目标入组 900 人开始时间: 2008年7月2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
- 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
- •Patients with all the following criteria will be eligible for enrolment:
- •- over 18 year-old male or female ambulatory patient,
- •- suffering from a seasonal allergic rhinitis to grass pollen grain defined by :
- •- 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 rhinorrhea and/or nasal blockade) for at least two years; if, for a 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 least to grass pollen grains, at selection visit or duly documented in the medical file within the last 6 months,
- •- with a nasal symptomatology score rated by the patient equal or superior to 6 at inclusion (maximal 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 least 2 months before the study and one month after the end of the 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
- •Patients with one of the following criteria will not be eligible for enrolment:
- •* 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.
- •Non inclusion criteria (Ctd):* Criteria related to treatments
- •- Medical history of hypersensitivity to mequitazine or drug excipients,
- •-Failure to a previous treatment with desloratadine
- •- Specific desensitization to grass pollens 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,
- •- Inhaled corticosteroid treatment within the last 4 weeks,
- •- Potent and/or superpotent topical corticosteroid within the last 4 weeks,
- •- Treatment by antileukotriene within the 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,
- •- Treatment by oxicams within the last 7 days,
- •- Regular treatment by nasal or oral decongestive drug within the last 7 days,
- •- Treatment by CYP2D6 (fluoxetine, paroxetine, quinidine, thioridazine, clomipramine, haloperidol)
- •- 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
- •- length 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 forfeited his/her freedom by administrative or legal award, or who is under guardianship,
- •- subject who cannot be contacted in case of emergency.
- •For women of childbearing potential:
- •- pregnancy or breast feeding.
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