Efficacy and safety assessment of Chlorhexidine hydrochloride - Lidocaine hydrochloride (MEDICA ®) versus placebo in adult patients with sore throat and/or acute pharyngitis

QUALIPHAR NV0 个研究点目标入组 202 人开始时间: 2014年3月19日最近更新: 2015年2月23日

适应症

试验速览

暂无简介。

•Disease related:
•- Non-bacterial pharyngitis and/or erythematous sore throat since less than 3 days
•- Mac Isaac Score < 2
•- Negative Rapid Strep Test (RST)
•- Tonsillopharyngitis Severity Score (TSS) = 5
•Population related:
•- Age over 18 years old
•- Written informed consent for the study participation
•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 202
•F.1.3 Elderly (>=65 years)
•F.1.3.1 Number of subjects for this age range

•Disease related:
•- Presence of peritonsillar or retropharyngeal abscess
•- Pseudo-membranous pharyngitis
•- Other causes of dysphagia and/or pharyngitis
•Treatment related:
•- Oral, local or injection antibiotic administration within the last 14 days preceding the enrolment
•- Oral or local steroidal or non-steroidal anti-inflammatory drugs within the last 48 hours preceding the enrolment
•Population related:
•- Pregnant women
•- Breast feeding women
•- Women in childbearing age not using an effective contraceptive method (hormonal or mechanical)
•- Inability to comply with the protocol
•- Linguistic or physiological inability to sign the informed consent form
•- Participation in a clinical trial during the previous three months

发起方

QUALIPHAR NV