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4月21日最近更新: 2019年6月30日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 900

研究概览入排标准研究者记录与标识符相似试验

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

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 selection visit, 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 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,
•- 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 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.

研究者

发起方

Pierre Fabre Médicament

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