Acute Otitis Media Clinical Trial
Official title:
Efficacy and Safety of an Herbal-Based Medication vs. Placebo in Preventing Acute Otitis Media in Children at High Risk of Recurrence: A Placebo Controlled, Randomized, Double-blinded Parallel-Group Comparison for Superiority
The purpose of this study is to study whether a herbal-based medication is superior to placebo for prevention of acute otitis media in pre-school children with upper respiratory tract infection.
This is a prospective, controlled parallel-group comparison for superiority of Otovowen®.
Patient will be identified by screening of patient cards. Patients with recurrent AOM aged 12
to 59 months will be randomly assigned either to Otovowen® or placebo. Randomization will be
stratified by age at enrolment (12-35 versus 36-59 months).
The observation period per subject will be 6 months. Data collection and documentation will
be performed weekly via online diary by the parents/legal representative(s) and by the
investigator via eCRF.
Patients will be seen by the doctor at baseline and at end of study. Unscheduled visits in
case of AOM or severe URI or any other disease are initiated by the parents/legal
representative(s).
Study medication will be sent to the patient/parents/legal representative(s) after
randomization. and will be administered at first signs or symptoms of URI (e. g. elevated
temperature, common cold, influenza, coughing, sore throat, hoarse voice, frequent sneezing,
running or stuffy nose, sinusitis, fever, headache, etc.) until resolved (maximally 8 weeks
of continuous application).
AOM will be diagnosed during unscheduled visits according to the criteria detailed in the
study protocol. An AOM will be considered as resolved through confirmation by the
investigator only.
Compliance will be assessed by weighing contents of bottles of IMPs.
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