EUCTR2010-023057-11-HU进行中（未招募）不适用
Efficacy and safety of rupatadine solution in the treatment of Chronic Spontaneous Urticaria (CSU) in paediatric patients (2-11 years old).
J. Uriach y Compañía, S.A.0 个研究点目标入组 192 人开始时间: 2011年2月10日最近更新:
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
- 192
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
- •Children can participate in the study if they meet all the following inclusion criteria:
- •(1) Boys and girls between 2 and 11 years old, inclusive, at screening.
- •(2) Weight >10 Kg.
- •(3) Documented history of chronic spontaneous urticaria (urticarial itchy wheals) with or without angioedema of at least 6 weeks before the selection visit.
- •(4) Patients with a cumulative score = 12 points in the adapted Urticaria Activity Score of the 7 days (adapted UAS7) before Visit 0.
- •UAS is defined as the sum of the scores (0-3) of the two symptoms assessed (pruritus and adapted number of wheals) in a daily basis. If the patients had a daily adapted UAS score of 6 (maximum severity) and they took second generation antihistamines as rescue medication, the following day cannot be counted for the adapted UAS7, due to carry-over effects of the antihistamine; and so seven valid individual days will be calculated counting backwards, beginning with the last day of the evaluation period.
- •(5) 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 < 450 msec.
- •(6) Children who have written consent from their parent/guardian to participate in the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 192
- •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
- •Children cannot enter in the study if they meet any of the following exclusion criteria:
- •(1)Patients with dermatological conditions such as hereditary angio-oedema or isolated dermographism, physical urticaria, urticaria caused by the ingestion of any drug or food, urticaria caused by any infection, contact urticaria, urticaria caused by vasculitis and/or collagenosis.
- •(2)Patient with any parasitic infestations enable to cause any urticaria like symptoms-signs (i.e. anisakiasis, strongyloidiasis, etc.).
- •(3)Patient under any systemic or topical medication for CU and/or an inferior wash-out period as stated (please check the protocol)
- •(4)Patient taking medication that is known to interact significantly with CYP3A4 isozyme of cytochrome P450 such as amiodarone, carbamazapine, cyclosporin, terfenadine, glucocorticoids, phenytoin, rifampicin, erythromycin, ketoconazole, antiretrovirals tricyclic antidepressants as well as grapefruit juice.
- •(5)Patient with clinically relevant abnormal laboratory values indicative of physical illness, or patient whose health could be harmed by their participation in the study at investigator criteria.
- •(6)Patient with ascertained of presumptive hypersensitivity to the active principle and/or formulation ingredients of the tested compounds such as children with lactose intolerance.
- •(7)History of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may impact on the outcome of the study.
- •(8)Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, haematological, endocrine or neurological diseases that may interfere with the aim of the study.
- •(9)Patient that after review of their medical history is considered by the investigator as unresponsive to antihistaminic treatment.
- •(10)Children or parents unable to comply with the study requirements (attendance to visits), unable to complete the patient diary and take the study treatment, or children that should have to travel to another geographic area during the course of the study.
- •(11)Girl who is pregnant or lactating.
- •(12)Children who have a recent history (within previous 12 months) of drug addiction or alcohol abuse.
- •(13)Children taking drugs strongly associated with torsade de pointes such as disopyramide, procainamide, quinidine, amiodarone, sotalol, thioridazine, beperidil or prenylamine.
- •(14)Participation in the evaluation of any drug within 3 months prior to the start of the study.
研究者
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