EUCTR2012-003506-27-PT进行中（未招募）不适用
A multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the safety and tolerability of 10 mg once daily bilastine in children from 2 to 11 years of age with either allergic rhinoconjunctivitis or chronic urticaria. - Bilastine, Safety and Tolerability study in Children (BISAFE)
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
- 504
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
- •(1) Boys and girls between 2 and 11 years old, inclusive, at screening.
- •(2) Documented history of allergic rhinoconjunctivitis (AR) or chronic urticaria (CU) with clinical symptoms at study entry.
- •(3) For AR patients, a positive skin prick test/RAST for at least one allergen.
- •(4) A 12 lead ECG obtained at screening within acceptable limits, moreover in absence of any drug effect or disease, QTc interval values (msec) after Fridericia’s correction must be normal (not prolonged). The values considered to be normal are lower than 440 msec.
- •(5) Children who have written consent from their parent(s)/guardian to participate in the study. Children should be informed according to their understanding (assent form will be obtained whenever possible).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 504
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •(1) Non-allergic rhinitis or acute urticaria.
- •(2) Intake of particular medications with antiallergenic activities or sedative properties.
- •(3) Known allergy/hypersensitivity to the study drug (bilastine) or its inactive ingredients.
- •(4) Patients who are taking or have taken any of the following medications prior to randomisation in the study and have not complied with the specified washout period of 7 days unless otherwise noted:
- •Oral corticosteroids.
- •Antihistamines: Loratadine/ desloratadine (10 days) other systemic antihistamines (3 days).
- •Anti-leukotrienes.
- •Delayed-release corticosteroids (3 months).
- •Ketotifen (2 weeks).
- •Macrolides antibiotics and imidazolic antifungals (systemic).
- •Anticholinergics.
- •Investigational medication or antibodies.
- •Regular schedule immunotherapy can be maintained throughout the study but will be disallowed from 24h prior to 24h after first study dosing.
- •(5) Clinically relevant abnormal laboratory values indicative of physical illness (including clinically significant ECG abnormalities as judged by the investigator; e.g. Wolff-Parkinson-White syndrome or long QT syndrome), or patient whose health could be harmed by their participation in the study at investigator criteria.
- •(6) Hypersensitivity to H1 antihistamines or benzimidazoles.
- •(7) Any clinical conditions or relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, haematological, endocrine or neurological diseases that in the opinion of the investigator would make the subject unsuitable for the study or interfere with the aim of the study.
- •(8) Children or parent(s) unable to comply with the study requirements (attendance to visits), unable to take the study treatment, or children that should have to travel to another geographic area during the course of the study.
- •(9) Girl who is pregnant or lactating.
- •(10) Children who have a recent history (within previous 12 months) of drug addiction or alcohol abuse.
- •(11) Participation in another clinical study within 30 days prior to the first study drug intake.
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