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

Registry ID

EUCTR2009-009037-14

Source registry

EUCTR

Status

Completed

Phase

PHASE2

Sponsor

Auris ehf.

Start date

2009-02-25

Completion date

2010-05-17

Last update

2026-08-16

Conditions

• Acute Otitis Media

Summary

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.

Locations

• , , Iceland

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