EUCTR2005-000358-65-GB进行中（未招募）不适用
A multicentre, double-blind, two parallel groups, randomized trial over four weeks oftreatment to compare the clinical efficacy and safety of Levocetirizine 5 mg oral capsules once daily in the morning vs. Desloratadine 5 mg oral capsules once daily in the morning in patients suffering from Chronic Idiopathic Urticaria (CIU)
CB S.A.0 个研究点目标入组 816 人开始时间: 2005年9月27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
- 816
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 be eligible to participate in this study, all of the following criteria must be met at
- •Visit 1(selection visit):
- •? Have been informed of the nature and aims of the study and have given their written informed consent signed and dated.
- •? Male or female patients 18 years or older.
- •? 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 bilateral ovariectomy or a congenital sterility. When sexually active, females of childbearing potential must be using a medically accepted contraceptive method (hormonal birth control, per os, injectable or by implant, for at least 2 months), have had a bilateral tubal ligation, have monogamous relationship with vasectomized partner or agree to use intrauterine device, diaphragm with spermicide or male condom with spermicide. The female subject must understand the consequences and potential risks of inadequately protected sexual activity, be educated about and understand the proper use of contraceptive method, and undertake to inform the Investigator of any potential change in status.
- •? Clinical history of Chronic Idiopathic Urticaria (i.e. episodes of hives of characteristic
- •wheal and flare appearance, occurring regularly, at least 3 times a week) for a period of at least 6 weeks during the last 3 months without an identifiable cause.
- •? Out-patients.
- •? Subjects considered as reliable and mentally capable of adhering to the protocol (i.e., completing the daily record card and questionnaires), according to the judgment of the Investigator.
- •The subjects should meet the following criteria at Visit 2 (randomization visit):
- •? Female subjects with childbearing potential are eligible if they have a negative urinepregnancy test at Visit 2.
- •? During the one-week baseline period for at least 3 days:
- •? The pruritus severity (over the last 24 hours) has to be minimum 2 and
- •? The number of wheal score (at the moment of evaluation) has to be =1.
- •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
- •Subjects must be excluded if they meet any of the following criteria at Visit 1:
- •? Be incapable of giving their written informed consent.
- •? Pregnancy or breast feeding.
- •? Have any of the following pathologies: senile pruritus; acute urticaria; cholinergic,
- •solar, heat, cold, water or drug-induced urticaria; isolated delayed pressure urticaria;
- •contact urticaria; urticarial vasculitis; or hereditary angioneurotic oedema.
- •? Have any dermatological disease that would interfere with evaluation of therapeutic response (e.g. generalized psoriasis, atopic dermatitis, contact dermatitis...).
- •? Have a history of autoimmune disorders, Hodgkin’s disease, lymphoma, leukemia and generalized cancer.
- •? Presence of other clinically significant disease (cardiovascular, hepatic, renal, autoimmune or associated with hematology, neurology, psychiatry) or any other disease which would disturb absorption, distribution, metabolism or excretion of the
- •investigational product.
- •? Subject intending to donate blood during the study.
- •? Have used the following medications within the specified wash-out periods (calculates in relation to V1) and during the course of the study:
- •Astemizole 12 weeks
- •Systemic and topical corticosteroids 4 weeks
- •Ketotifen 2 weeks
- •Loratadine, desloratadine 10 days
- •Doxepin 10 days
- •Other systemic antihistamines (H1 and H2) 3 days
- •Leucotrienes antagonists (e.g.: montelukast) 3 days
- •Tranquilizers, antidepressants, sedatives, hypnotics, antiepileptics and other CNS active agents: No wash out period
- •Nonsteroidal anti-inflammatory drugs: No wash out period
- •? Be hypersensive to levocetirizine or its excipients, desloratadine or to any other
- •piperazine derivatives such as hydroxyzine, cetirizine, cyclizine, meclozine or
- •? Be expected non compliant with the investigational products or with the protocol
- •requirements.
- •? Have a known lack of response to H1- antihistamines.
- •? Have a history of alcoholism, drug addiction or mental instability.
- •? Have participated in a clinical trial during the last three months before V1.
- •Subjects must be excluded at Visit 2 if they meet any of the following criteria:
- •? Have a baseline period (Visit 1-Visit 2) inferior to three days or superior to nine days.
- •? No recording for at least three distinct days of presence of pruritus score > 2 and/or
- •number of wheals score > 1.
- •? Have taken any prohibited medication during the baseline period.
- •? Have presented any of the exclusion criteria checked at Visit 1 during the baseline
研究者
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