EUCTR2006-003686-13-DE进行中（未招募）1 期
An exploratory phase III, randomised, double blind, therapeutic single dose-related effect, parallel group study to assess and compare the effects of 5mg vs. 20mg Desloratadine on skin lesions in patients with chronic urticaria (CU). - AUD2OC
Allergie-Centrum-Charite, Department of Dermatology, Charite - Universitätsmedizin Berlin0 个研究点目标入组 30 人开始时间: 2007年3月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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.Outpatients with moderate to severe CU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch.
- •2.Patients must exhibit spontaneous urticaria lesions at the randomization visit.
- •3.History of beneficial effects of antihistaminic treatment.
- •4.Age between 18 and 75 years.
- •5.Female patients must be using adequate contraceptive precautions (highly effective method), or they must be postmenopausal, surgically sterilised, or hysterectomised. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed.
- •6.Voluntarily signed written informed consent.
- •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
- •1.The presence of permanent severe diseases, especially those affecting the immune system, except CU.
- •2.The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of gastrointestinal tract).
- •3.History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia.
- •4.History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy.
- •5.Evidence of severe renal dysfunction
- •6.Evidence of significant hepatic disease (liver enzymes twice the upper reference value).
- •7.The presence of galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption.
- •8.History of adverse reactions including hypersensitivity to DL and Loratadine.
- •9.Intake of medicaments that could cause QT changes (drugs listed on www.qtdrugs.org).
- •10.Presence of active cancer which requires chemotherapy or radiation therapy.
- •11.Presence of acute urticaria / angioedema including laryngeal edema
- •12.History or presence of alcohol abuse or drug addiction.
- •13.Participation in any clinical trial within 4 weeks prior to enrolment.
- •14.Intake of oral corticosteroids or other immunosuppressive therapy within 14 days prior to the beginning of the study.
- •15.Use of depot corticosteroids or chronic systemic corticosteroids within 21 days before beginning of the study.
- •16.Pregnancy or breast-feeding.
- •17.Existing or planned placement in an institution after ruling according to § 40 passage 1 number 4 AMG (Arzneimittelgesetz).
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