NCT01444196已完成4 期
Multi-center, Double Blind, Dose Escalating Study to Compare the Effects of 5 mg, 10mg and 20mg of Desloratadine in Patients With Acquired Cold Urticaria (ACU)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- CTTs and CSTTs assessed by TEMPtest 3.0 + urticaria network SOPs
研究概览
简要总结
The primary objective of the study is to assess the dosis of DL which is sufficient to inhibit cold urticaria symptoms.
详细描述
A total of 30 patients (male and female) with ACU will be included in this study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent signed and dated
- •Reliable method of contraception for both women of childbearing potential as well as man during the study and 3 months thereafter. 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
- •Outpatients with ACU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch.
- •Age between 18 and 75 years
排除标准
- •Subjects who are inmates of psychiatric wards, prisons, or other state institutions. Existing or planned placement in an institution after ruling according to § 40 passage 1 number 4 AMG (Arzneimittelgesetz).
- •The presence of permanent severe diseases, especially those affecting the immune system, except urticaria and cold urticaria
- •The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of gastrointestinal tract)
- •History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia
- •History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy
- •Evidence of severe renal dysfunction
- •Evidence of significant hepatic disease (liver enzymes twice the upper reference value)
- •History of adverse reactions to DL
- •Presence of active cancer which requires chemotherapy or radiation therapy
- •Presence of alcohol abuse or drug addiction
- •Intake of oral corticosteroids within 14 days prior to screening visit
- •Use of depot corticosteroids or chronic systemic corticosteroids within 21 days prior to screening visit
- •Use of systemic immunosupressants/immunomodulators like ciclosporine A, dapsone, methotrexate, mycophenolate, chloroquine, and comparable drugs within 28 days prior to screening visit.
- •Pregnancy or breast-feeding
研究组 & 干预措施
Desloratadine dose
Other
- Study group: 5 mg Desloratadine during the whole study
- Study group: 5 mg every day for 14 (+-2 days) start with Visit 2, 10 mg every day for 14 (+-2 days) start with Visit 3, 20 mg every day for 14 (+-2 days) start with Visit 4.
干预措施: Desloratadine (Drug)
Dose of Desloratadine
Other
- Study group: 5 mg Desloratadine during the whole study
- Study group: 5 mg every day for 14 (+-2 days) start with Visit 2, 10 mg every day for 14 (+-2 days) start with Visit 3, 20 mg every day for 14 (+-2 days) start with Visit 4.
干预措施: Desloratadine (Drug)
结局指标
主要结局
CTTs and CSTTs assessed by TEMPtest 3.0 + urticaria network SOPs
时间窗: 6 weeks
次要结局
- Presence of wheal(s) at 4°C Intensity of pruritus and burning Number and duration of angioedemas QoL as assessed by DLQI Severity of ACU (by ACUSI)(6 weeks)
研究者
Marcus Maurer
Head of Research Dept. of Dermatology
Charite University, Berlin, Germany
研究点 (1)
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