EUCTR2007-007657-31-DE进行中（未招募）不适用
Efficacy and safety of Miltefosine in antihistamine resistant chronic urticaria - MIARC
Charité-University Berlin0 个研究点开始时间: 2008年2月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Outpatients with moderate to severe spontaneous CU defined by UAS of =15 (under the maximum labelled dose of a non-sedating antihistamine.
- •Resistant to standard treatment with antihistamines after a minimum of 7 days therapy with the maximum labelled dose of a non-sedating antihistamine (levocetrizine, cetiricine, fexofenadine, desloratidine, loratidine, ebastine, mizolastine
- •Aged over 18 years
- •Reliable method of contraception for women of childbearing potential (i.e. low failure rate less than 1% per year) during the study and 3 months thereafter
- •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
- •Pregnancy or lactation
- •Participation in another clinical trial within the last 30 days
- •Body weight < 47 kg
- •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).
- •Skin symptoms caused primarily by physical urticaria
- •Urticaria vasculitis
- •Known hypersensitivity to miltefosine
- •Gastrointestinal disturbances which may influence oral resorption (e.g. chronic diarrhoea diseases, congenital malformations or major surgical resection of gastrointestinal tract).
- •History within 5 years or presence of myocardial infarction or any other major cardiac disorder.
- •Serum-creatinine and/or BUN 1.5 times above the upper reference value)
- •GOT and/or GPT and/or alkaline phosphatase 3 times above the upper reference value).
- •Sjögren-Larsson-Syndrome.
- •Malignancy within the last 5 years requiring chemotherapy or radiation therapy.
- •Mental disorders
- •Drug or alcohol dependency
- •Any other chronic or acute illness requiring systemic treatment which might have any influence on the outcome of the study in the 4 weeks before start of treatment and during the study (investigator’s decision).
- •Immunodeficiency including HIV
- •During the past 7 days before start of treatment and during the study
- •Topical steroids
- •H2 antihistamines
- •Leukotriene antagonists
- •H1 antihistamine other then basic therapy
- •During the past 2 weeks before start of treatment and during the study
- •During the past 4 weeks before start of treatment and during the study
- •Systemic corticosteroids
- •UV therapy including PUVA
- •Systemic immunosuppressives including corticosteroids, immunomodulators, immunostimulants
- •During the past 12 weeks before start of treatment and during the study
- •Tranquilizers, antidepressants, sedatives, hypnotics, antiepileptics and other CNS active agents
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