Cross-Over Study of the Decongestant Effect of Phenylephrine Compared With Placebo and Pseudoephedrine as Active Control in SAR Subjects Exposed to Pollen in the Vienna Challenge Chamber

Schering Plough Research Institute0 个研究点目标入组 39 人开始时间: 2005年11月23日最近更新: 2013年4月22日

适应症

试验速览

暂无简介。

•1. Skin test positive for the grass pollen allergen used in the chamber at screening or within the prior 12 months.
•2. A negative urine pregnancy test at screening and at monthly intervals for female subjects of childbearing potential.
•3. The following minimum scores at some point during each of the 120-minute screening periods challenge sessions:
•a. nasal congestion scoreof at least 2 (moderate)
•b. total nasal symptoms score of at least 6
•c. total non-nasal symptoms score of at least 2
•4. Freedom from any clinically significant disease, other than SAR, that would interfere with the study evaluations.
•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

•1. An upper or lower respiratory tract infection within 4 weeks before screening.
•2. Dependence upon nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids, in the opinion of the investigator.
•3. A known potential for hypersensitivity, allergy, or idiosyncratic reaction to the study drug or excipients.

发起方