A randomised, blinded, phase IIa, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of repeat doses of thymol solution 4% administered to the outer ear canal of children two years of age or older, suffering from mild to moderate acute otitis media

Auris ehf.0 个研究点目标入组 75 人开始时间: 2009年1月23日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•1.Two years of age or older at randomisation
•2.Written informed consent obtained from subject’s parent or legal guardian
•3.Confirmed diagnosis of mild to moderate AOM by a ENT specialist (confirmed by an otoscopic examination and tympanometry)
•4.Intact tympanic membrane
•5.Ability of the parent or legal guardian to understand and comply with the requirements of the protocol
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years)
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years)
•F.1.3.1 Number of subjects for this age range

•Individuals are excluded from participation in the study if any of the following criteria apply on Day 1 of study.
•1.Lacking informed consent
•2.Severe AOM (clinical assessment of the ENT specialist and supported by high body temperature (above 39°C) and composite score of TM parameters 9-13, see protocol section 14.4.1
•3.History of hypersensitivity to thymol
•4.Ear infection during the last 4 weeks prior to randomisation
•5.Known renal dysfunction
•6.Known hepatic dysfunction
•7.Known diabetes
•8.Chronic seizure or neurologic disorder
•9.Congenital heart disease
•10.Chromosomal defects (children with Down’s syndrome)
•11.Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy
•12.Anatomical changes in ear and nearby structures, e.g. skeletal abnormalities or persisting changes following a fracture of the base of the skull
•13.Cleft palte
•14.Ear surgery, especially if artificial implants have been used (does not apply to grommets)
•15.Perforated tympanic membrane
•16.Grommets in situ
•17.Receipt of an investigational product within 30 days prior to enrolment or expected receipt during this study

发起方

Auris ehf.