Acute Otitis Media
Conditions
Interventions
Product Name: Thymol 4% Solution
Pharmaceutical Form: Ear drops*
Pharmaceutical form of the placebo: Ear drops, solution
Route of administration of the placebo: Auricular use
Sponsors
Auris ehf.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy, safety and tolerability of thymol 4% solution when administered to the ear canal of children diagnosed with mild or moderate AOM compared to placebo. The subject’s immune profile (MBL, IgG and sub-classes and CRP) will be assessed for exploratory purposes. ;Secondary Objective: ;Primary end point(s): The analysis of efficacy endpoints (response to treatment/healing) will be based on all subjects randomised who complete treatment with investigational medicinal product according to protocol. Analysis will be performed on the efficacy data collected during visit 1 (baseline), visit 2 (end of treatment visit) and at follow-up visit (visit 3) taking place 5 days + 1 day following last treatment. Reduction of the composite score at end of treatment and at the end of follow-up will be calculated and compare between treatment groups using appropriate statistical methods as described below: As a primary efficacy analysis, the proportion of “healing” patients at Visit 2 and Visit 3, as measured using the composite score, where healing is defined as an improvement to ‘Cured’ or ‘Minimal AOM’. The difference between healing proportion of the the test and placebo products will be tested using proportion test (Z-test) at 0.05 level of significance, if the assumptions of normality are satisfied. Nonparametric statistical methodologies will be used when the assumptions of normality are not met. The proportion of “healing” patients, as measured using the composite score, will be compared using a chi-square test. | — |
Countries
Iceland
Outcome results
None listed