EUCTR2008-008734-36-HU进行中（未招募）不适用
EFFICACY AND SAFETY STUDYOF THE ANTIHISTAMINE V0114CP 2.5MGIN THE TREATMENT OF SEASONAL ALLERGIC RHINITIS.RANDOMISED, DOUBLE-BLIND, THREE ARM PARALLEL GROUP STUDYINCLUDING PLACEBO AND ACTIVE CONTROL ARM (LEVOCETIRIZINE 5 MG).
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
- •Patients with all the following criteria will be eligible for enrolment:
- •- male or female ambulatory patient,
- •- no less than 12 year-old (or no less than 18year-old according to National Legislation)
- •- suffering from a seasonal allergic rhinitis to grass and or weed pollen grain defined by :
- •-- a documented medical history of seasonal rhinitis during the grass/weed pollen season (mainly April to October) 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 and or weed 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, and/or whose parent(s) or guardian(s) has(have) given his/her(their) written consent for their child's participation in the study,
- •- able to understand the protocol and to attend the control visits, and/or whose parent(s) or guardian(s) is(are) cooperative with regard to compliance with study-related constraints,
- •- if required by national regulation, registered with a social security or health insurance system and/or whose parent(s) or guardian(s) is(are) registered with a social security or health insurance system.
- •For girls/women of childbearing potential:
- •- use of an efficient contraceptive (implants, injectable, patch or combined oral contraceptives, some intra-uterine devices for at least 2 months before the study and one month after the end of the study,
- •- negative urine pregnancy test at selection visit.
- •Are the trial subjects under 18? yes
- •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, neuropsychiatric 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 (GINA II and higher),
- •- Chronic alcoholism,
- •- History of agranulocytosis,
- •- Congenital galactosemia, malabsorption syndrome to glucose or galactose, or lactase deficiency,
- •- Seizure,
- •- Iatrogenic rhinitis,
- •- Nasal polyposis or severe deviation of the nasal septum,
- •- History of any 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.
- •- Chronic neurologic or psychiatric diseases
- •*Criteria related to treatments:
- •- Medical history of hypersensitivity to mequitazine or drug excipients,
- •- Medical history of hypersensitivity to levocetirizine, to other piperazine derivatives, or to any of the excipients
- •- Severe renal impairment at less than 10 ml/min creatinine clearance
- •- Hereditary problems of galactose intolerance, glucose-galactose malabsorption, lactase deficiency
- •- Failure to a previous treatment with levocetirizine,
- •- Anti-allergy immunotherapy to grass and or weed pollens
- •-- with increase of allergen challenges in the previous 2 years
- •-- at any dose in the previous 6 months
- •- Depot corticosteroid treatment within the last 6 months,
- •- Oral, nasal, injectable (intramuscular, intravenous, intra-articular, intraspinal) corticosteroid treatment within the last 4 weeks,
- •- Ocular, inhaled, potent or superpotent topical corticosteroid treatment within the last 2 weeks,
- •- Treatment by antileukotriene within the 7 days,
- •- Treatment by cromone or ketotifen within the last 1 week,
- •- Treatment by H1 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 inhibitors (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, or parent(s) or guardian(s) subject who, in the judgement of the investigator is/are not likely to be compliant during the study,
- •- patient linguistically or psychologically unable to understand the information given or formulate his/her informed consent or who refuses to give his/her consent in writing or parent(s) or guardian(s) linguistically or psychologically unable to understand the information given or to give his/her(their) informed consent or who refuses(refuse) to give his/her(their) consent in writing,
- •- patient subject to an administrative or court orde
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