E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Acute middle ear infection |
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E.1.1.2 | Therapeutic area | Diseases [C] - Ear, nose and throat diseases [C09] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Do lidocaine drops as added to usual care provide superior parent-reported ear pain relief over the first three days compared to usual care in children aged between 1 and 6 years with a GP-diagnosis of AOM and ear pain? |
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E.2.2 | Secondary objectives of the trial |
Do lidocaine drops as added to usual care lead to a lower proportion of children consuming antibiotics for AOM and fewer analgesic consumption in the first 7 days compared to usual care? Do lidocaine drops as added to usual care reduce the overall symptom burden in the first 7 days? Do lidocaine drops as added to usual care lead to fewer days with ear pain, GP reconsultations with/without subsequent antibiotic prescribing for AOM and improved generic and disease-specific quality of life at 4 weeks compared to usual care? Are lidocaine drops safe in children with AOM (in terms of adverse events during treatment, AOM complications during follow-up)? What is the cost effectiveness of lidocaine ear drops as added to usual care for children with AOM compared to usual care? What are parents’ views and experience of treatment acceptability, usability and satisfaction? What are clinicians’ views and experience of treatment acceptability, usability and impact on consultation? |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Mean parent-reported ear pain score (using a 0-10 validated numerical rating scale) over the first three days. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
As specified in primary end point definition |
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E.5.2 | Secondary end point(s) |
- proportion of children consuming antibiotic in de first 7 days; - oral analgesic use in the first 7 days; - overall symptom burden (incl. episodes of crying or distress, disturbed sleep, interference with normal activity, appetite, fever and hearing problems) using the 0-6 Likert scale in the first 7 days; - number of days with ear pain during follow up (4 weeks); - number of GP reconsultations with/without subsequent antibiotic prescribing during follow-up; - adverse events during follow-up; - complications of AOM during follow-up; - generic quality of life (using the 47-item short-form of the Infant Toddler Quality of Life Questionnaire (ITQOL-SF47)) of the child at 4 weeks; - disease-specific quality of life (Otitis media-6 (OM-6)) questionnaire of the child at 4 weeks; - costs and cost-effectiveness at 4 weeks; - parents’ and GPs’ views of treatment acceptability, usability and satisfaction (nested mixed methods process evaluation). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
As specified in secondary end points definitions |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |