Analgesic ear drops for children with acute middle ear infectio

Phase 1

• Conditions: Acute otitis media; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2021-003019-24-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-06
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
-Age 1 to 6 years
-Parent-reported ear pain in 24 hours prior to enrolment
-GP-diagnosis of (uni- or bilateral) AOM
Are the trial subjects under 18? yes
Number of subjects for this age range: 300
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
-Children with (suspected) tympanic membrane perforation or ventilation tubes
-Children with ear wax obscuring visualisation of the tympanic membrane
-Children who are systemically very unwell or require hospital admission (e.g. child has signs and symptoms of serious illness and/or complications such as mastoiditis/meningitis).
-Children who are at high risk of serious complications including children with known immunodeficiency other than partial IgA or IgG2 deficiencies, craniofacial malformation including cleft palate, Down syndrome and previous ear surgery (with the exception of ventilation tubes in the past).
-Children who have a known allergy or sensitivity to study medication or similar substances (e.g. other amide-type anaesthetics, bupivacaine, mepivacaine, prilocaine)
-Children who have taken part in any research involving medicines within the last 90 days, or any other AOM-related research within the last 30 days.
-Children who suffer from chronic recurrent pain of another origin than the ear.
-Children who have participated in this trial during prior AOM episode.

Study & Design

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