EUCTR2010-021001-21-DE进行中（未招募）不适用
An exploratory, randomised, double-blind, placebo controlled crossover study to assess the efficacy of 20 mg Rupatadine on the treatment of mastocytosis symptoms - Study on Mastocytosis for Rupatadine Treatment
Allergie-Centrum-Charité0 个研究点开始时间: 2010年6月16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
- •- Chronic stable symptomatic maculopapulous cutaneous mastocytosis or indolent systemic mastocytosis with skin involvement and a positive Darier's Sign
- •- Age between 18 and 70 years
- •- Female patients must be using a highly effective method of birth control (such as implants injectables, combined oral contraceptives, some IUDs, sexual abstinence, vasectomised partner), or they must be postmenopausal, surgically sterilised, or hysterectomised.
- •- Voluntarily signed written informde 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
- •- The presence of permanent severe diseases, especially those affecting the immune system, except for mastocytosis
- •- 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, hyper-/hypokalemia, bradycardia < 50bpm, QTc interval > 440ms
- •- Evidence of severe renal dysfunction (creatinine > 1,5 x upper reference value)
- •- Evidence of significant hepatic disease (liver enzymes > 2 x upper reference value)
- •- History of adverse reactions to RUP, or other ingredients of the IMP
- •- Presence of active cancer which requires chemotherapy or radiation therapy
- •- Aggressive systemic mastocytosis
- •- History or presence of alcohol abuse or drug addiction
- •- Participation in any clinical trial within 4 weeks prior to enrolment
- •- Commitment to an institution in terms of 40 Abs. 1 Nr. 4 AMG
- •- Intake of antihistamines or leukotriene antagonists within 7 days prior to the beginning of the study
- •- Intake of oral corticosteroids within 14 days prior to the beginning of the study
- •- Use of depot corticosteroids or chronic systemic corticosteroids within 21 days before beginning of the study
- •- Pregnancy or breast-feeding
研究者
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