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

Phase 1

• Conditions: Acute Otitis Media

• Registration Number: EUCTR2009-009037-14-IS
• Lead Sponsor: Auris ehf.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-23
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified