EUCTR2004-002823-42-DE进行中（未招募）不适用
A multicentre, double-blind, parallel, randomized, placebo-controlled study :Evaluation of the efficacy and safety of Levocetirizine 5 mg and Desloratadine 5 mgadministered orally as capsules once daily, in the morning, over 2 weeks in patientssuffering from Seasonal Allergic Rhinitis (SAR) due to grass pollen
CB S.A. Pharma Sector0 个研究点目标入组 729 人开始时间: 2005年3月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 729
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
- •To enter the study, subjects should meet the following criteria:
- •Be informed of the nature and aims of the study (refer to ICF) and be their written
- •informed consent to participate in this study
- •Male or female out subject aged =18 years
- •Female subjects of childbearing potential must agree not to become pregnant during thestudy. Female subjects are considered of non-childbearing potential before menarche,or at least two years after menopause, or if they had a total hysterectomy or a bilateralovariectomy or a congenital sterility. When sexually active, females of childbearingpotential must be using either oral contraceptives, contraceptive trans-dermal device,contraceptive injections for at least two months; have had a bilateral tubal ligation; havemonogamous relationship with vasectomized partner or agree to use intra-uterinedevice, diaphragm with spermicide, or male condom with spermicide.
- •Be able to understand the information given and the text of the informed consent, tocomplete the daily record card (See Appendix 18.1), as well as to discuss with the
- •Investigator.
- •At least 2-year history of seasonal allergic rhinitis that became symptomatic during theannual grass pollen season.
- •A skin test or a RAST (Radio Allergo Sorbent Test) for grass pollens :
- •a skin prick test is positive when the wheal is > 3mm larger than the diluent
- •a RAST is positive if > class 3 or > 3.5 IU/mL.
- •These tests must have been performed during the preceding year. If none is available, a
- •skin test should be performed at Visit 1.
- •Have rhinitis symptoms of such severity that the mean T4SS (Total 4 Symptom Score:
- •Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus) over the baseline period must be=6. The mean T4SS is calculated taking into account only the days on which the
- •scores of these four symptoms are available. For this reason, the selection period can be reduced up to three days or increased up to seven days if necessary.
- •The rhinitis symptoms (Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and
- •Nasal Congestion) must be evaluated and recorded on the diary card by the subjects
- •using the following scale:
- •0 = Absent
- •1 = Mild (present but not disturbing)
- •2 = Moderate (disturbing but not hampering daytime activities and/or sleep)
- •3 = Severe (hampering daytime activities and / or sleep)
- •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
- •To enter study at Visit 1, subjects should not:
- •Be pregnant (positive urinary pregnancy test) or lactating,
- •Have an ear, nose, throat (ENT) infection during the two weeks preceding Visit 1 (e.g.sinusitis, purulent rhinorrhea, common cold…),
- •Have an associated asthma requiring corticosteroid treatment,
- •Have an atopic dermatitis or an urticaria requiring an antihistamine treatment or the
- •administration of oral or topical corticosteroids,
- •Have an associated ENT disease such as vasomotor rhinitis, significant chronic
- •sinusitis, obstructive nasal polyposis, obstructive deviation of the nasal septum, rhinitismedicamentosa,
- •Have another clinically significant disease (cardiovascular, hepatic, renal, auto-immuneor associated with hematology, neurology, psychiatry), or any other disease whichwould disturb absorption, distribution, metabolism or excretion of the investigationalproducts,
- •Be initiating or changing the dose of an immunotherapy regimen during the course ofthe study or during the preceding month
- •Have to use during the course of the study any of the following medications or have
- •used them within the specified wash-out periods :
- •intranasal or systemic corticosteroids 30 days
- •ketotifen 14 days
- •nedocromil, cromoglicate 14 days
- •other topical corticosteroids 14 days
- •loratadine, desloratadine 10 days
- •leukotriene antagonists or synthesis inhibitors 7 days
- •other antihistamines 3 days
- •decongestants (per os, nasal spray or drops) 3 days
- •Be hypersensitive to levocetirizine or its excipients, or to any other piperazine
- •derivatives such as hydroxyzine, cetirizine, cyclizine, meclozine, buclizine,
- •Be hypersensitive to desloratadine or its excipients.
- •Known lack of response to H1-antihistamine treatment,
- •Be incapable of giving their written informed consent,
- •Be expected to be non compliant with the study treatments or with the requirements of the protocol,
- •Have a history of alcoholism, drug addiction, mental instability,
- •Have participated in a clinical trial during the last three months,
- •Have already been selected in this study,
- •Be intending to donate blood during the study,
- •Be neither an investigator, a co-investigator, their children or spouses, nor anyone of the study co-workers
- •To continue the study at Visit 2, subjects should not:
- •Have a selection period (Visit 1-Visit 2) inferior to three days or superior to seven days
- •Have a mean T4SS < 6 over the selection period
- •Have taken any prohibited medication during the selection period
- •Have presented during the selection period with any of the exclusion criteria checked at Visit1
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