EUCTR2007-003572-19-LV进行中（未招募）不适用
EFFICACY AND SAFETY STUDY OF THE ANTIHISTAMINE V0114CP 2.5MG IN THE TREATMENT OF PERENNIAL ALLERGIC RHINITIS. RANDOMISED, DOUBLE-BLIND, THREE ARM PARALLEL GROUP STUDY INCLUDING PLACEBO AND ACTIVE CONTROL ARM (LEVOCETIRIZINE 5 MG)
Pierre Fabre Médicament0 个研究点目标入组 1,080 人开始时间: 2008年2月26日最近更新:
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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
- 1,080
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 perennial allergic rhinitis (dust mite, animal dander, cockroaches) defined by :
- •- a recorded medical history of perennial rhinitis with symptoms (sneezing and/or nasal 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 recorded, the clinical diagnosis will be assessed by the score for allergic rhinitis (SFAR),
- •NB: patients having episode(s) of symptomatic seasonal allergic rhinitis are eligible if the period 1 of the study (first 6 weeks) is performed out of the expected period(s) of the concerned seasonal allergens (e.g.: chestnut, grey alder, cypress, silver birch, mimosa, white ash, wall pellitory).
- •- a positive prick test and/or positive specific IgE (class ³3 or equivalent) to the concerned allergen(s) (dust mite, animal dander, cockroaches), duly documented in the medical file within the past 12 months,
- •- with an instantaneous morning nasal symptom score ³ 6 during at least 4 days during the 7 days before inclusion (maximal score: 12),
- •- in case of associated bronchial asthma, will be allowed only mild intermittent asthma, not requiring corticosteroids treatment,
- •- 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 contraceptive method (oral contraceptive, intra-uterine device, tubal ligature),
- •- 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 was not compatible with the participation to the study in the opinion of the investigator,
- •- Any acute or chronic disease that did not allow with the participation to the study in the opinion of the investigator,
- •- Chronic alcoholism,
- •- History of agranulocytosis,
- •- Congenital galactosemia, malabsorption syndrom to glucose or galactose, or lactase deficiency,
- •- Seizure,
- •- Severe nasal obtruction (score = 3),
- •- Iatrogenic rhinitis,
- •- Nasal polyposis or severe deviation of the nasal septum,
- •- History of nasal surgery,
- •- Acute or chronic rhinosinusitis, as defined by EP3OS guideline,
- •- Upper respiratory tract infection within the last 3 weeks.
- •Criteria related to treatments
- •- Medical history of hypersensitivity to mequitazine or drug excipients,
- •- Specific desensitization to perennial allergens finished within the last 6 months, whatever the issue,
- •- Depot corticosteroid treatment within the last 6 months,
- •- Oral, intramuscular or intravenous corticosteroid treatment within the last 8 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
- •- QTc interval > 450 ms,
- •- poor compliance for fulfilling the diary during the selection period, as judged by the investigator,
- •- 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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