EUCTR2008-005442-23-BG进行中（未招募）不适用
Evaluation of the efficacy and safety of nose spray containing 3% silver protein diacetyl tannate (SEAT) in patients with uncomplicated viral rhinitis. A placebo-controlled, randomized, multicentric Phase III trial.
eyh Pharma GmbH0 个研究点目标入组 100 人开始时间: 2009年2月28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
- 入组人数
- 100
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]patients with uncomplicated viral rhinitis
- •[2]rating of rhinitis symptoms by investigator of at least moderate” at baseline
- •[3]age between 18 and 55 years
- •[4]informed consent given in written form according to chapter 125H5.4 of study protocol.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •[1]duration of current common cold symptoms of more than 48 hours
- •[2]diagnosis of any other infectious disease that produces also symptoms of common cold but needs specific treatment with antibacterial or antiviral drugs (e.g. bronchitis, pneumonia etc.)
- •[3]any other concomitant drug treatment of symptoms of common cold
- •[4]any concomitant physical therapy of symptoms of common cold
- •[5]changes in existing concomitant therapy with corticosteroids, or other drugs with influence on the immune system (e.g. immunosuppressive or cytostatic agents)
- •[6]participation in another clinical trial at same time or within the preceding 3 months except for previous bioequivalence trials in which case at least 8 weeks are sufficient
- •[7]history of drug abuse or use of illegal drugs: use of soft drugs, e.g. marihuana within 6 months of screening or hard drugs, e.g. cocaine, amphetamines, phencyclidine within 1 year of screening
- •[8]alcohol abuse, i.e. regular use of more than 2 units of alcohol per day or 10 units per week or a history of alcoholism (one unit of alcohol equals 250 ml beer, 125 ml wine or 25 ml spirits) or recovered alcoholics
- •[9]allergic diathesis or any clinically significant allergic disease (i.e. asthma or bronchial hyperreactivity or allergic rhinitis)
- •[10]any history of drug hypersensitivity (especially to the active and inactive ingredients of the silver protein diacetyl tannate preparation)
- •[11]severe physical or mental concomitant diseases that might hamper the realization of the trial according to protocol or the evaluation of efficacy or safety
- •[12]pregnancy or lactation period
- •[13]legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study
- •[14]evidence of an uncooperative attitude.
研究者
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