Randomized, prospective double-blinded study to evaluate safety and efficacy of Angocin Anti-Infekt N versus placebo in the prophylaxis of respiratory tract infections - AngoPA

Repha GmbH0 个研究点开始时间: 2010年11月4日最近更新: 2012年5月8日

适应症

试验速览

暂无简介。

•Adult volunteers of both sexes who have suffered in the previous cold season at least 2 acute infection of the respiratory tract,
•subjects aged 18 to 75 years,
•signed ICF (informed consent form)
•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

•serious chronic diseases,
•serious diseases of the psyche,
•known hypersensitivity to any of the components of the study medication,
•simultaneous participation in a clinical study or participation in a clinical trial within the previous 30 days before enrollment,
•pregnant women, nursing mothers or women planning a pregnancy, women of childbearing age who operate no adequate contraception,
•subjects with a disease or in a situation that exposed the opinion of the investigator the subjects a significant risk of prejudice the study results or influence them significantly,
•abnormal laboratory values,
•taking antibiotics within 3 weeks prior to study implementation,
•chronic infections of the respiratory tract,
•allergic rhinitis,
•influenza and pneumonia vaccine during the study
•alcohol and drug abuses
•previous participation in a study within the last 30 days
•pregnancy and lactation
•known hypersensitivity of one of the ingredients of the IMP and placebo

发起方

Repha GmbH