Overview

This trial is active, not recruiting.

Condition acute otitis media
Treatments herbal-based medication, placebo
Phase phase 3
Sponsor University Hospital Tuebingen
Start date October 2013
End date October 2015
Trial size 296 participants
Trial identifier NCT02345447, OTV.PRE.01.A3

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
Trade Name of active comparator: Otovowen® Substances: Aconitum napellus Dil. D6; Capsicum annuum Dil. D4; Chamomilla recutita; Echinacea purpurea; Hydrargyrum bicyanatum Dil. D6; Hydrastis canadensis Dil. D4; Iodum Dil. D4; Natrium tetraboracicum Dil. D4; Sambucus nigra; Sanguinaria canadensis. Manufacturer: Weber & Weber, Inning/Ammersee Dose: Three times daily 7 drops Mode of Application: orally Duration of Treatment: at first signs of Upper respirtory tract infection until symptoms resolve (maximally 8 weeks of continuous application).
herbal-based medication Otovowen(R)
Aconitum napellus, Capsicum annuum; Chamomilla recutita; Echinacea purpurea; Hydrargyrum bicyanatum; Hydrastis canadensis; Iodum; Natrium tetraboracicum; Sambucus nigra; Sanguinaria canadensis
(Placebo Comparator)
Placebo Substance: Aqueous ethanol solution non-distinguishable from verum. Manufacturer: Weber & Weber, Inning/Ammersee Dose: Three times daily 7 drops Mode of Application: orally Duration of Treatment: at first signs of URI until symptoms resolve (maximally 8 weeks of continuous application).
placebo
Aqueous ethanol solution non-distinguishable from verum

Primary Outcomes

Measure
Number of acute otitis media episodes diagnosed by a physician
time frame: within 6 months after enrolment per patient

Secondary Outcomes

Measure
Total number of acute otitis media per treatment group
time frame: diagnosed in each patient within 6 months after enrolment
Number of unscheduled visits due to AOM
time frame: within 6 months after enrolment
Number of AOM treated with antibiotics
time frame: within 6 months after enrolment
Number of unscheduled visits due to URI
time frame: within 6 months after enrolment
Number of URI treated with antibiotics
time frame: within 6 months after enrolment
Number of days with URI
time frame: within 6 months after enrolment
Subjective evaluation of efficacy by parent
time frame: at indivdual study completion 6 months after enrolment
Subjective evaluation of tolerability by parent
time frame: at indivdual study completion 6 months after enrolment
Occurence of adverse events
time frame: within 6 months of enrolment
number of days with use of antipyretic, analgesic and antibiotic medication
time frame: within 6 months of enrolment
Number of absent days from daycare (patient) / work (parent)
time frame: within 6 months of enrolment

Eligibility Criteria

Male or female participants from 12 months up to 59 months old.

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.

Additional Information

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
Principal investigator Axel Franz, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University Hospital Tuebingen.