Clinical trial NCT02345447: Herbal-Based Medication vs. Placebo in Preventing Acute Otitis Media in Children at High Risk of Recurrence
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Otitis Media
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 296
Sex: ALL
Minimum age (years): 12
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Children with at least 3 episodes of acute otitis media (AOM) within 12 months prior to study inclusion as documented in their medical records. Diagnosis criteria for AOM see study protocol
* parental written consent

Exclusion Criteria:

* Ongoing acute otitis media or URI
* Current prophylaxis/treatment for URI or AOM
* Current use of phytotherapeutic and homeopathic agents with secretolytic, anti-inflammatory or immune enhancing properties
* Use of tympanostomy tubes
* Chronic tympanic membrane perforation (TMP)
* Palatine cleft
* Parents/legal representative(s) of children unable to follow study procedures, who have no internet access and are not willing to use an online diary on a weekly basis
* History of hypersensitivity to the investigational drug or to its ingredients.
* Systemic, severe as well as history of uncontrolled chronic disease or a concurrent clinically significant illness, or medical condition, which in the investigator's opinion, would contraindicate study participation or compliance with protocol mandated procedures.
* Simultaneous participation in another clinical trial or participation in any clinical trial involving an investigational medicinal product within 30 days prior to written informed consent for this trial.

Primary outcomes:
measure: Number of acute otitis media episodes diagnosed by a physician
timeFrame: within 6 months after enrolment per patient
Secondary outcomes:
measure: Total number of acute otitis media per treatment group
timeFrame: diagnosed in each patient within 6 months after enrolment
measure: Number of unscheduled visits due to AOM
timeFrame: within 6 months after enrolment
measure: Number of AOM treated with antibiotics
timeFrame: within 6 months after enrolment
measure: Number of unscheduled visits due to URI
timeFrame: within 6 months after enrolment
measure: Number of URI treated with antibiotics
timeFrame: within 6 months after enrolment
measure: Number of days with URI
timeFrame: within 6 months after enrolment
measure: Subjective evaluation of efficacy by parent
timeFrame: at indivdual study completion 6 months after enrolment
measure: Subjective evaluation of tolerability by parent
timeFrame: at indivdual study completion 6 months after enrolment
measure: Occurence of adverse events
timeFrame: within 6 months of enrolment
measure: number of days with use of antipyretic, analgesic and antibiotic medication
timeFrame: within 6 months of enrolment
measure: Number of absent days from daycare (patient) / work (parent)
timeFrame: within 6 months of enrolment
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Children's Hospital Tuebingen
Study officials:
affiliation: University Hospital Tuebingen
name: Axel Franz, MD
role: PRINCIPAL_INVESTIGATOR
References: